Teco Diagnostics
Anaheim, CA, US
TECO DIAGNOSTICS appears in FDA device records in Anaheim, CA. FDA records list 55 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 10 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 55FDA records hold 55 510(k) clearances for Teco Diagnostics between 1993 and 2017. The busiest year on record is 1997, with 8. The most recent is 2017, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 2 |
| 1994 | 3 |
| 1995 | 4 |
| 1996 | 6 |
| 1997 | 8 |
| 1998 | 2 |
| 2000 | 2 |
| 2001 | 2 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2005 | 6 |
| 2006 | 3 |
| 2007 | 2 |
| 2008 | 2 |
| 2011 | 3 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 2 |
| 2017 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K170118 | Scanostics UTI Check Application Test System | JMT | Substantially Equivalent | |
| K161527 | Teco Creatinine Enzymatic Reagent Kit | JFY | Substantially Equivalent | |
| K170200 | Carbon Dioxide Reagent Set | KHS | Substantially Equivalent | |
| K160372 | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM | JIL | Substantially Equivalent | |
| K152835 | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM | JFY | Substantially Equivalent | |
| K141289 | TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS | JIL | Substantially Equivalent | |
| K131600 | URS-2GP (GLUCOSE PROTEIN) URINE STRIPS | JIL | Substantially Equivalent | |
| K111206 | TECO DIAGNOSTICS SALIVA ALCOHOL TEST | DIC | Substantially Equivalent | |
| K100024 | TECO DIAGNOSTICS UTI DETECTION STRIPS | JMT | Substantially Equivalent | |
| K101673 | URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10 | JIL | Substantially Equivalent | |
| K073370 | TC MATRIX CLINICAL CHEMISTRY ANALYZER | JJE | Substantially Equivalent | |
| K072548 | CREATINE KINASE LIQUID REAGENT, MODEL C519-440 | CGS | Substantially Equivalent | |
| K063701 | TECO HOMOCYSTEINE ENZYMATIC ASSAY | LPS | Substantially Equivalent | |
| K061419 | TECO MICROALBUMIN 2-1 COMBO STRIPS | JIR | Substantially Equivalent | |
| K061065 | FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25 | KHE | Substantially Equivalent | |
| K060364 | VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE | JKA | Substantially Equivalent | |
| K060120 | TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM | CDQ | Substantially Equivalent | |
| K052724 | TECO ISE REAGENT SET FOR CX SYSTEM | JGS | Substantially Equivalent | |
| K051526 | URITEK-720+ URINE ANALYZER | KQO | Substantially Equivalent | |
| K051200 | HEMOGLOBIN A1C REAGENT SET | LCP | Substantially Equivalent | |
| K051121 | DIRECT LDL CHOLESTEROL, MODEL L530-60H | MRR | Substantially Equivalent | |
| K050823 | DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR | LBR | Substantially Equivalent | |
| K042421 | URITEK 151 URINE ANALYZER, MODEL TC-151 | KQO | Substantially Equivalent | |
| K040920 | AMYLASE LIQUID REAGENT, MODEL A532-200 | JFJ | Substantially Equivalent | |
| K023297 | URS-1B (BLOOD TEST) | JIO | Substantially Equivalent | |
| K020175 | URS-IG (GLUCOSE TEST) | JIL | Substantially Equivalent | |
| K010239 | COCAINE DIPSTICK TEST, MODEL D747-A | DIO | Substantially Equivalent | |
| K003987 | URS-1K (KETONE TESST) | JIN | Substantially Equivalent | |
| K000102 | GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150 | CFR | Substantially Equivalent | |
| K000067 | ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H | CJE | Substantially Equivalent | |
| K981650 | AST/SGOT LIQUID REAGENT - KINETIC METHOD | CIT | Substantially Equivalent | |
| K981106 | UREA NITROGEN (BUN) LIQUID REAGENT | CDQ | Substantially Equivalent | |
| K970579 | ONE STEP MORPHINE CARD TEST | DNK | Substantially Equivalent | |
| K970548 | ONE STEP MARIJUANA CARD TEST | LDJ | Substantially Equivalent | |
| K970250 | CLINISTRIP | JIL | Substantially Equivalent | |
| K970120 | BILE ACIDS REAGENT SET | KWW | Substantially Equivalent | |
| K970124 | LIPASE REAGENT SET (COLIPASE METHOD) | CET | Substantially Equivalent | |
| K964536 | ONE-STEP DIPSTICK PREGNANCY TEST | JHI | Substantially Equivalent | |
| K964462 | ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TEST | JHI | Substantially Equivalent | |
| K964461 | ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST | JHI | Substantially Equivalent | |
| K962019 | C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST | DCK | Substantially Equivalent | |
| K962015 | RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST | DHR | Substantially Equivalent | |
| K961864 | CSF/URINE TOTAL PROTEIN | CEK | Substantially Equivalent | |
| K961629 | THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST | JLW | Substantially Equivalent | |
| K954977 | URINE REAGENTS STRIPS-8 PARAMETERS (MODIFICATION) | JRE | Substantially Equivalent | |
| K955438 | URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION) | JIR | Substantially Equivalent | |
| K943436 | URINE REAGENT STRIPS-8 PARAMETERS | JJB | Substantially Equivalent | |
| K942648 | IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET | JIL | Substantially Equivalent | |
| K942735 | CARBON DIOXIDE (C02) | KHS | Substantially Equivalent | |
| K941427 | SERUM @-HYDROXYBUTYRATE DEHYDROGENASE (HBDH) | JMK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1832216 | 1832216 | TECO DIAGNOSTICS | 1268 NORTH LAKEVIEW AVE., ANAHEIM, CA 92807 US | 2026 | and 112 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CKBAcid Phosphatase, Naphthyl Phosphate
- CKEAcid Phosphatase, Thymolphthale Inmonophosphate
- GFOActivated Partial Thromboplastin
- DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
- CGXAlkaline Picrate, Colorimetry, Creatinine
- DRRAmplifier And Signal Conditioner, Biopotential
- GMQAntigens, Nontreponemal, All
- CDLBerthelot Indophenol, Urea Nitrogen
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- DIHColorimetry, Cholinesterase
- CICCresolphthalein Complexone, Calcium
- GJZCyanomethemoglobin Reagent And Standard Solution
- DJZDevices, Breath Trapping, Alcohol
- CIGDiazo Colorimetry, Bilirubin
- CIQDiazo, Ast/Sgot
- CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJREnzyme Immunoassay, Methadone
- DJGEnzyme Immunoassay, Opiates
- DBFFerritin, Antigen, Antiserum, Control
- DJJFluorometry, Morphine
- CGAGlucose Oxidase, Glucose
- CFRHexokinase, Glucose
- CKDHydrazone Colorimetry, Alt/Sgpt
- DGCIge, Antigen, Antiserum, Control
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CHJMercuric Thiocyanate, Colorimetry, Chloride
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CETOlive Oil Emulsion (Turbidimetric), Lipase
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- GGNPlasma, Coagulation Control
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CFLRadioimmunoassay, Human Growth Hormone
- CEPRadioimmunoassay, Luteinizing Hormone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
- CDPRadioimmunoassay, Total Triiodothyronine
- DKEReagents, Test, Tetrahydrocannabinol
- CFDSulfophosphovanillin, Colorimetry, Total Lipids
- DCNSystem, Test, C-Reactive Protein
- DHRSystem, Test, Rheumatoid Factor
- DHCSystem, Test, Systemic Lupus Erythematosus
- CEJTetraphenyl Borate, Colorimetry, Potassium
- CFHTetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
- DJCThin Layer Chromatography, Methamphetamine
- DNKThin Layer Chromatography, Morphine
- CIOThymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
- CEIUranyl Acetate/Zinc Acetate, Sodium
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0512-2012 | Urine Reagent Strips (URS) 11 Parameters URS-11-100G-001 510(K) number: K970250 Devise Listing number: D072377 Each Device consists of 100 strips of Urine Reagent Strips 11 parameters packed with a desiccant pouch inside a black bottle with Cortez Diagnostics Label on the bottle and the bottle placed inside a Cortez Diagnostics Box. | This recall was initiated in response to findings during a FDA inspection of the firm. The firm's recall has been initiated due to improper manufacture of sub-component nitrite paper Lot 35134, Expiration Date: 01/2014. Discrepancies were found on the information recorded on formulation sheet and manufacturing log sheets. Sampling size submitted for QC testing was insufficient based upon number o | Terminated | ||
| Z-0511-2012 | Urine Reagent Strips (URS) 10 Parameters URS-l0-100W 510(K) number: K970250 Devise Listing number: D072377 Each device consists of 100 strips of Urine Reagent Strips 10 parameters packed with a desiccant pouch inside a gray bottle with Teco Diagnostics Label on the bottle and the bottle placed inside a Teco Diagnostics Box. For the semi-quantitative and qualitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes in urine. | This recall was initiated in response to findings during a FDA inspection of the firm. The firm's recall has been initiated due to improper manufacture of sub-component nitrite paper Lot 35134, Expiration Date: 01/2014. Discrepancies were found on the information recorded on formulation sheet and manufacturing log sheets (Refer to next paragraph). Sampling size submitted for QC testing was insuff | Terminated | ||
| Z-0583-2011 | NDC, Inc. Pro Advantage Urine Analyzer, Catalog Number: Pro Advantage Urine Analyzer The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses advanced testing technology of a cold-light source, integrating sphere, and modularized blocking systematical design which enhances the stability of the optical system. This system also automatically compensates for the influence of ambient and scattered lights through the coordination of software and hardware. The TC-101 can test for 10 parameters including Glucose (GLU), Urobilinogen (URO), Bilirubin (BIL), Ketone (KET), Specific Gravity (SG), Occult Blood (BLD), pH, Protein (PRO), Nitrite (NIT), Leukocytes (LEU) in 60 seconds when used with Urine Reagent Strips (URS) 10. | This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for use in measuring urinary glucose or occult blood with the CLIA waived, Inc. CLIA-10 test strips. Teco Diagnostics has been notified by the FDA that the CLIA-101 requires 510(k) clearance and is not CLIA Waived for use with the CLIA-10 test strips. Without FDA approval or clearance, Teco Di | Terminated | ||
| Z-0582-2011 | McKesson Medical Surgical 107-101 Urine Analyzer, Catalog Number: 107-101 The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses advanced testing technology of a cold-light source, integrating sphere, and modularized blocking systematical design which enhances the stability of the optical system. This system also automatically compensates for the influence of ambient and scattered lights through the coordination of software and hardware. The TC-101 can test for 10 parameters including Glucose (GLU), Urobilinogen (URO), Bilirubin (BIL), Ketone (KET), Specific Gravity (SG), Occult Blood (BLD), pH, Protein (PRO), Nitrite (NIT), Leukocytes (LEU) in 60 seconds when used with Urine Reagent Strips (URS) 10. | This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for use in measuring urinary glucose or occult blood with the CLIA waived, Inc. CLIA-10 test strips. Teco Diagnostics has been notified by the FDA that the CLIA-101 requires 510(k) clearance and is not CLIA Waived for use with the CLIA-10 test strips. Without FDA approval or clearance, Teco Di | Terminated | ||
| Z-0581-2011 | Immunostics, Inc. Detector UriStrip Urine Analyzer, Catalog Number: Detector UriStrip Urine Analyzer The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses advanced testing technology of a cold-light source, integrating sphere, and modularized blocking systematical design which enhances the stability of the optical system. This system also automatically compensates for the influence of ambient and scattered lights through the coordination of software and hardware. The TC-101 can test for 10 parameters including Glucose (GLU), Urobilinogen (URO), Bilirubin (BIL), Ketone (KET), Specific Gravity (SG), Occult Blood (BLD), pH, Protein (PRO), Nitrite (NIT), Leukocytes (LEU) in 60 seconds when used with Urine Reagent Strips (URS) 10. | This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for use in measuring urinary glucose or occult blood with the CLIA waived, Inc. CLIA-10 test strips. Teco Diagnostics has been notified by the FDA that the CLIA-101 requires 510(k) clearance and is not CLIA Waived for use with the CLIA-10 test strips. Without FDA approval or clearance, Teco Di | Terminated | ||
| Z-0580-2011 | Henry Schein, Inc. OneStep Pro Urine Analyzer, Catalog Number: OneStep Pro Urine Analyzer The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses advanced testing technology of a cold-light source, integrating sphere, and modularized blocking systematical design which enhances the stability of the optical system. This system also automatically compensates for the influence of ambient and scattered lights through the coordination of software and hardware. The TC-101 can test for 10 parameters including Glucose (GLU), Urobilinogen (URO), Bilirubin (BIL), Ketone (KET), Specific Gravity (SG), Occult Blood (BLD), pH, Protein (PRO), Nitrite (NIT), Leukocytes (LEU) in 60 seconds when used with Urine Reagent Strips (URS) 10. | This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for use in measuring urinary glucose or occult blood with the CLIA waived, Inc. CLIA-10 test strips. Teco Diagnostics has been notified by the FDA that the CLIA-101 requires 510(k) clearance and is not CLIA Waived for use with the CLIA-10 test strips. Without FDA approval or clearance, Teco Di | Terminated | ||
| Z-0579-2011 | Cole Taylor Marketing, Inc. CT-101 Urine Analyzer, Catalog Number: CT-101 The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses advanced testing technology of a cold-light source, integrating sphere, and modularized blocking systematical design which enhances the stability of the optical system. This system also automatically compensates for the influence of ambient and scattered lights through the coordination of software and hardware. The TC-101 can test for 10 parameters including Glucose (GLU), Urobilinogen (URO), Bilirubin (BIL), Ketone (KET), Specific Gravity (SG), Occult Blood (BLD), pH, Protein (PRO), Nitrite (NIT), Leukocytes (LEU) in 60 seconds when used with Urine Reagent Strips (URS) 10. | This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for use in measuring urinary glucose or occult blood with the CLIA waived, Inc. CLIA-10 test strips. Teco Diagnostics has been notified by the FDA that the CLIA-101 requires 510(k) clearance and is not CLIA Waived for use with the CLIA-10 test strips. Without FDA approval or clearance, Teco Di | Terminated | ||
| Z-0578-2011 | Cliawaived, Inc. CLIA-101 Urine Analyzer, Catalog Number: CLIA-101 The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses advanced testing technology of a cold-light source, integrating sphere, and modularized blocking systematical design which enhances the stability of the optical system. This system also automatically compensates for the influence of ambient and scattered lights through the coordination of software and hardware. The TC-101 can test for 10 parameters including Glucose (GLU), Urobilinogen (URO), Bilirubin (BIL), Ketone (KET), Specific Gravity (SG), Occult Blood (BLD), pH, Protein (PRO), Nitrite (NIT), Leukocytes (LEU) in 60 seconds when used with Urine Reagent Strips (URS) 10. | This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for use in measuring urinary glucose or occult blood with the CLIA waived, Inc. CLIA-10 test strips. Teco Diagnostics has been notified by the FDA that the CLIA-101 requires 510(k) clearance and is not CLIA Waived for use with the CLIA-10 test strips. Without FDA approval or clearance, Teco Di | Terminated | ||
| Z-0577-2011 | Teco Diagnostics Uritek TC-101 Urine Analyzer, Catalog Number: TC-101 The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses advanced testing technology of a cold-light source, integrating sphere, and modularized blocking systematical design which enhances the stability of the optical system. This system also automatically compensates for the influence of ambient and scattered lights through the coordination of software and hardware. The TC-101 can test for 10 parameters including Glucose (GLU), Urobilinogen (URO), Bilirubin (BIL), Ketone (KET), Specific Gravity (SG), Occult Blood (BLD), pH, Protein (PRO), Nitrite (NIT), Leukocytes (LEU) in 60 seconds when used with Urine Reagent Strips (URS) 10. | This recall has been initiated due to the CLIA-101 Urine Analyzer not having 510(k) clearance by the FDA for use in measuring urinary glucose or occult blood with the CLIA waived, Inc. CLIA-10 test strips. Teco Diagnostics has been notified by the FDA that the CLIA-101 requires 510(k) clearance and is not CLIA Waived for use with the CLIA-10 test strips. Without FDA approval or clearance, Teco Di | Terminated | ||
| Z-0472-06 | Uritek TC-101Urine Analyzer, catalog number TC-101 | When reading the Nitrite parameter on the Teco Diagnostics URS-10 strips, some positive nitrite samples may be read by the machine as negative. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain