ELITechGroup Inc
Logan, UT, US
ELITechGroup Inc appears in FDA device records in Logan, UT. FDA records list 32 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 10 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to ELITechGroup Inc carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Vital Diagnostics Pty., Ltd.510(k), enforcement report, recall
- Wescor, Inc.510(k), recall
510(k) clearance history
FDA records hold 32 510(k) clearances for ELITechGroup Inc between 1983 and 2018. The busiest year on record is 2011, with 6. The most recent is 2018, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 3 |
| 1984 | 3 |
| 1985 | 1 |
| 1988 | 4 |
| 2001 | 1 |
| 2011 | 6 |
| 2012 | 3 |
| 2013 | 3 |
| 2014 | 2 |
| 2015 | 2 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K180559 | HSV 1 & 2 ELITe MGB Kit; ELITe InGenius | PGI | Substantially Equivalent | |
| K180627 | Macroduct Advanced Model 3710 | KTB | Substantially Equivalent | |
| K171401 | ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 | CIG | Substantially Equivalent | |
| K153644 | ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II | CFR | Substantially Equivalent | |
| K151113 | ELITech Clinical Systems CALCIUM ARSENAZO | CJY | Substantially Equivalent | |
| K151552 | ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II | JIX | Substantially Equivalent | |
| K141265 | ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT | JHW | Substantially Equivalent | |
| K132399 | ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL | JFY | Substantially Equivalent | |
| K130765 | ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II | JIX | Substantially Equivalent | |
| K121823 | CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC | JFS | Substantially Equivalent | |
| K122177 | ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL | JIT | Substantially Equivalent | |
| K122858 | ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II | JFJ | Substantially Equivalent | |
| K122083 | ELITECH CLINICAL SYSTEMS CK NAC SL | JHW | Substantially Equivalent | |
| K120202 | EON CHOLESTEROL REAGENT | CHH | Substantially Equivalent | |
| K113269 | ELITTECH CLINICAL SYSTEMS ALP IFCC SL | CJE | Substantially Equivalent | |
| K111960 | ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS | KHS | Substantially Equivalent | |
| K110780 | ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II | CIG | Substantially Equivalent | |
| K111996 | ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2 | JJY | Substantially Equivalent | |
| K112029 | ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05 | JIX | Substantially Equivalent | |
| K110830 | ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH | CIX | Substantially Equivalent | |
| K010031 | NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM | KTB | Substantially Equivalent | |
| K863395 | WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER | CGZ | Substantially Equivalent | |
| K881592 | WESCOR MODEL 7300 AEROSPRAY GRAM STAINER | KPA | Substantially Equivalent | |
| K881512 | WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAY | JTS | Substantially Equivalent | |
| K880544 | WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAY | GJL | Substantially Equivalent | |
| K853973 | WESCOR MODEL 3700 WEBSTER SWEAT INDUCER | KTB | Substantially Equivalent | |
| K834214 | WESCOR 5500 VAPOR PRESSURE OSMOMETER | JJM | Substantially Equivalent | |
| K834208 | COLLOID OSMOMETER 4400 | JJM | Substantially Equivalent | |
| K840472 | SYS MACRODUCT SWEAT COLLECTION SYS 3600 | KTB | Substantially Equivalent | |
| K833295 | WESCOR 7100 AEROSPRAY SLIDE STAINER | KPA | Substantially Equivalent | |
| K830429 | WEIL PERFUSOMETER #100 | FLL | Substantially Equivalent | |
| K833260 | STAIN PACK FOR AEROSPRAY SLIDE STAINER | IAF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1717966 | 1717966 | ELITechGroup Inc | 370 West 1700 South, LOGAN, UT 84321 US | 2026 | and 16 more, listed in full below |
| 3011461582 | 3011461582 | ELITechGroup S.p.A. | Corso Svizzera 185, Torino Piedmont 10149 IT | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- LCPAssay, Glycosylated Hemoglobin
- CJYAzo Dye, Calcium
- CIXBromcresol Green Dye-Binding, Albumin
- JIXCalibrator, Multi-Analyte Mixture
- JISCalibrator, Primary
- JITCalibrator, Secondary
- JFJCatalytic Methods, Amylase
- JMZComparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality
- FLLContinuous Measurement Thermometer
- JFSCoulometric, Chloride
- IFBCytocentrifuge
- GKBDevice, Automated Sedimentation Rate
- KTBDevice, Iontophoresis, Specific Uses
- CIGDiazo Colorimetry, Bilirubin
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- JJPElectrode, Ion Selective (Non-Specified)
- CEMElectrode, Ion Specific, Potassium
- JGSElectrode, Ion Specific, Sodium
- CGZElectrode, Ion-Specific, Chloride
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- JFYEnzymatic Method, Creatinine
- KHSEnzymatic, Carbon-Dioxide
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- PPMGeneral Purpose Reagent
- PGIHerpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
- CFRHexokinase, Glucose
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- JJMOsmometer For Clinical Use
- LJGQuality Control Slides
- OOIReal Time Nucleic Acid Amplification System
- GJLRomanowsky Stains
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- KPASlide Stainer, Automated
- JTSStains, Microbiologic
- JHWU.V. Method, Cpk Isoenzymes
- JNAVapor Pressure, Osmolality Of Serum & Urine
- IAFWright'S Stain
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0733-2014 | Consult Diagnostics Eon Calcium Reagent For In-Vitro Diagnostic Use PN: 1429 For the quantitative measurement of calcium in plasma and serum | High positive calcium bias on plasma sample versus results on serum | Class II | Terminated | |
| Z-0732-2014 | Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN 55285 For the quantitative measurement of calcium in plasma and serum | High positive calcium bias on plasma sample versus results on serum | Class II | Terminated | |
| Z-1816-2010 | Excyte Slider Barcode Tube Adapter used with Excyte Vacuum or Non-Vacuum ESR Tubes. Single Use. Product Number: EX-I0552. Manufactured by Vital Diagnostics S.R.L., Italy. Slider allows a larger label to be applied to the ESR tube. | The tube may fall out or separate from the Slider adapter | Terminated | ||
| Z-1029-2010 | SS-H2O Aerospray Deionized Water, 500 mL, IVD, Wescor, Inc, Logan, Utah 84321. | Stains used for diagnostic use may be contaminated with bacteria. | Terminated | ||
| Z-1028-2010 | SS-035CG, Hematology Reagent C Eosin Stain, 1 U.S. Gallon, IVD, Wescor, Inc, Logan, Utah 84321. Specifically for use on the Wescor 7120 Hematology Aerospray Slide Stainer and is intended for use by medical professionals to stain specimens that may include blood and other body fluids as a step of standard laboratory practice in diagnosing disease in humans. | Stains used for diagnostic use may be contaminated with bacteria. | Terminated | ||
| Z-1027-2010 | SS-035C, Hematology Reagent C Eosin Stain, 500 mL, IVD, Wescor, Inc, Logan, Utah 84321. Specifically for use on the Wescor 7120 Hematology Aerospray Slide Stainer and is intended for use by medical professionals to stain specimens that may include blood and other body fluids as a step of standard laboratory practice in diagnosing disease in humans. | Stains used for diagnostic use may be contaminated with bacteria. | Terminated | ||
| Z-1234-2010 | ATAC Serum Control Kit. The device is used for monitoring the performance of clinical chemistry methods within the clinical range. | Vital Diagnostics observed a bias in the Quality Control Consensus Program between published values for ALP on the ATAC 8000 and reported customer means. The ranges were adjusted to reflect the analyzer population. | Terminated | ||
| Z-1233-2010 | Envoy 500 Serum Control Kit. The device is used for monitoring the performance of clinical chemistry methods within the clinical range. | Vital Diagnostics observed a bias in the Quality Control Consensus Program between published values for ALP on the ATAC 8000 and reported customer means. The ranges were adjusted to reflect the analyzer population. | Terminated | ||
| Z-1351-2008 | Osmocoll, COP Control Reference, SS-038, Contents: 6 unit packages of 1 mL vials (3 each High and Low), Wescor, Inc., 459 South Main Street, Logan, Utah 84321. | Inaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing. | Terminated | ||
| Z-1350-2008 | Osmocoll, COP Calibrator/Osmolality Control, SS-025, 6 unit packages- 1 mL vials (Normal), Manufactured for Wescor, Inc., 459 South Main Street, Logan, Utah 84321. | Inaccurate readings; The control does not provide an accurate calibration value/readings when performing Colloid Osmotic Pressure (COP) testing. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain