Technicon Instruments Corp.
Mchenry, IL, US
Technicon Instruments Corp. appears in FDA device records in Mchenry, IL. FDA records list 157 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 157
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 157FDA records hold 157 510(k) clearances for Technicon Instruments Corp. between 1976 and 1991. The busiest year on record is 1988, with 24. The most recent is 1991, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1977 | 13 |
| 1978 | 7 |
| 1979 | 7 |
| 1980 | 7 |
| 1981 | 5 |
| 1982 | 4 |
| 1983 | 6 |
| 1984 | 16 |
| 1985 | 9 |
| 1986 | 11 |
| 1987 | 6 |
| 1988 | 24 |
| 1989 | 17 |
| 1990 | 18 |
| 1991 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K914888 | TECHNICON CHEM 1(TM) SYST (GEN2 SYST) | CIX | Substantially Equivalent | |
| K914511 | TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL | LBS | Substantially Equivalent | |
| K914025 | TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P) | CIT | Substantially Equivalent | |
| K912616 | TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES | KLI | Substantially Equivalent | |
| K912413 | CHEM-LINK DATA BASE MANAGER | JJQ | Substantially Equivalent | |
| K903825 | DRUG OF ABUSE ANALYSIS SYSTEM | DIS | Substantially Equivalent | |
| K903824 | DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY | DKZ | Substantially Equivalent | |
| K903305 | TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD | KHS | Substantially Equivalent | |
| K903306 | TECHNICON CHEM I SYSTEM MAGNESIUM METHOD | JGJ | Substantially Equivalent | |
| K901410 | TECHNICON RA-2000(TM) SYSTEM | JJC | Substantially Equivalent | |
| K902243 | TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES | KLS | Substantially Equivalent | |
| K901124 | CHEM I CLINICAL ANALYZER URINE MAGNESIUM | JGJ | Substantially Equivalent | |
| K901123 | CHEM 1 CLINICAL ANALYZER URINE UREA NITROGEN | CDQ | Substantially Equivalent | |
| K901229 | CHEM 1 CLINICAL ANALYZER (METHOD URINE CREATININE) | CGX | Substantially Equivalent | |
| K900943 | MODIFIED TECHNICON DPA-1(TM) SYSTEM | DEW | Substantially Equivalent | |
| K900717 | TECHNICON TESTPOINT(TM) LIGAND CONTROL | JJY | Substantially Equivalent | |
| K901693 | TECHNICON CHEM 1 CLINICAL ANALYZER FOR URINE URIC | KNK | Substantially Equivalent | |
| K901226 | CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM) | CIC | Substantially Equivalent | |
| K901137 | CHEM 1 CLINICAL ANALYZER (URINE INORGANIC PHOSPHO) | CEO | Substantially Equivalent | |
| K900905 | TECHNICON AXON SYSTEM REAGENT METHODS | CKA | Substantially Equivalent | |
| K901122 | TECHNICON CHEM 1 CLINICAL ANALYZER URINE GLUCOSE | CFR | Substantially Equivalent | |
| K900593 | TECHNICON H*2(TM) SYSTEM | GKZ | Substantially Equivalent | |
| K896829 | TECHNICON RA SYSTEMS SODIUM (COLORIMETRIC METHOD) | JGT | Substantially Equivalent | |
| K895664 | TECHNICON DAX SYSTEM - POTASSIUM (ISE) METHOD | CEM | Substantially Equivalent | |
| K895672 | TECHNICON DAX SYSTEM - SODIUM (ISE) METHOD | JGS | Substantially Equivalent | |
| K895808 | TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN | DCF | Substantially Equivalent | |
| K894575 | TECHNICON RA SYSTEM THYROXINE T4 METHOD | CDX | Substantially Equivalent | |
| K893913 | TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD | KLB | Substantially Equivalent | |
| K893912 | TECHNICON RA SYSTEMS GENTAMICIN TEST METHOD | LCD | Substantially Equivalent | |
| K894574 | TECHNICON DPA-1 SYSTEM RF METHOD | DHR | Substantially Equivalent | |
| K892930 | TECHNICON DAX TM SYSTEM ADDITIONAL ANALYTES | CKA | Substantially Equivalent | |
| K892929 | TECHNICON AXON TM SYSTEM ADDITIONAL ANALYTES | CHJ | Substantially Equivalent | |
| K892198 | TECHNICON DPA-1 (TM) CRP METHOD | DCK | Substantially Equivalent | |
| K885203 | TECHNICON DAX(TM) SYSTEM | JJG | Substantially Equivalent | |
| K885226 | TECHNICON AXON(TM) SYSTEM | JJE | Substantially Equivalent | |
| K884748 | TECHNICON CHEM 1 SYSTEM ACID PHOS (PROSTATIC) | JFH | Substantially Equivalent | |
| K884747 | TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL) | CKB | Substantially Equivalent | |
| K884601 | TECHNICON SYSTEMS RA-100/ASSIST CHLORIDE | CHJ | Substantially Equivalent | |
| K884599 | TECHNICON RA-100 SYSTEM CALCIUM METHOD | CIC | Substantially Equivalent | |
| K884600 | TECHNICON SYSTEM RA-100/ASSIST MAGNESIUM | JGJ | Substantially Equivalent | |
| K884433 | TECHNICON ASSIST(R) CALCIUM METHOD | CIC | Substantially Equivalent | |
| K883586 | TECHNICON RA-100 SYSTEM POTASSIUM | CEJ | Substantially Equivalent | |
| K883585 | TECHNICON ASSIST POTASSIUM | CEJ | Substantially Equivalent | |
| K884419 | TECHNICON RA-PHENOBARBITAL | DLZ | Substantially Equivalent | |
| K884217 | TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN | LKL | Substantially Equivalent | |
| K883104 | CHEM 1 UIBC (IRON BINDING CAPACITY TEST) | JMO | Substantially Equivalent | |
| K883326 | TECHNICON RA(TM) SYSTEMS - MAGNESIUM | JGJ | Substantially Equivalent | |
| K883493 | TECHNICON DPA-1 IMMUNOGLOBULIN M | DFL | Substantially Equivalent | |
| K883492 | TECHNICON DPA-1 IMMUNOGLOBULIN A | CZP | Substantially Equivalent | |
| K883209 | TECHNICON RA-100(TM) SYSTEM | JJE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JFHAcid Phosphatase (Prostatic), Tartrate Inhibited
- CKBAcid Phosphatase, Naphthyl Phosphate
- CDOAcid, Uric, Uricase (U.V.)
- DCFAlbumin, Antigen, Antiserum, Control
- CGXAlkaline Picrate, Colorimetry, Creatinine
- DEMAlpha-1-Antitrypsin, Antigen, Antiserum, Control
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- JJCAnalyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
- JJGAnalyzer, Chemistry, Centrifugal, For Clinical Use
- JJFAnalyzer, Chemistry, Micro, For Clinical Use
- GMQAntigens, Nontreponemal, All
- DPAApparatus, General Use, Thin Layer Chromatography
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- JIXCalibrator, Multi-Analyte Mixture
- JFJCatalytic Methods, Amylase
- CZWComplement C3, Antigen, Antiserum, Control
- DBIComplement C4, Antigen, Antiserum, Control
- CHSCoulometric Method, Carbon-Dioxide
- GKLCounter, Cell, Automated (Particle Counter)
- GKZCounter, Differential Cell
- CICCresolphthalein Complexone, Calcium
- CIGDiazo Colorimetry, Bilirubin
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- CEMElectrode, Ion Specific, Potassium
- JGSElectrode, Ion Specific, Sodium
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- DIPEnzyme Immunoassay, Diphenylhydantoin
- DLZEnzyme Immunoassay, Phenobarbital
- JGTFlame Photometry, Sodium
- DAHGamma Globulin, Antigen, Antiserum, Control
- CGAGlucose Oxidase, Glucose
- CFRHexokinase, Glucose
- CZPIga, Antigen, Antiserum, Control
- DEWIgg, Antigen, Antiserum, Control
- DFLIgm, Ferritin, Antigen, Antiserum, Control
- JFRIndirect Copper Assay, Ceruloplasmin
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- CHJMercuric Thiocyanate, Colorimetry, Chloride
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- JFLPh Rate Measurement, Carbon-Dioxide
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JIYPhotometric Method, Iron (Non-Heme)
- JGJPhotometric Method, Magnesium
- IEOProcessor, Tissue, Automated
- CGRRadioimmunoassay, Cortisol
- DONRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.
- CEERadioimmunoassay, Thyroxine-Binding Globulin
- CDXRadioimmunoassay, Total Thyroxine
- CDPRadioimmunoassay, Total Triiodothyronine
- CIJSaccharogenic, Amylase
- DHRSystem, Test, Rheumatoid Factor
- CEJTetraphenyl Borate, Colorimetry, Potassium
- DPEThin Layer Chromatography, Diphenylhydantoin
- JEJTubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating)
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain