Vitek Systems, Inc.
Medical device manufacturer in Hazelwood, MI.
39510(k) clearances
0PMA approvals
0recalls
Device types
- JTO Discs, Strips And Reagents, Microorganism… 4
- JSS Kit, Identification, Enterobacteriaceae 3
- JSP Kit, Anaerobic Identification 3
- DLJ Calibrators, Drug Specific 2
- JXB Kit, Identification, Yeast 2
- CEP Radioimmunoassay, Luteinizing Hormone 2
- LJC Enzyme Linked Immunoabsorbent Assay… 2
- CGJ Radioimmunoassay, Follicle-Stimulating… 1
- LFZ Enzyme Linked Immunoabsorbent Assay… 1
- LQM Gram Negative Identification Panel 1
- LGC Enzyme Linked Immunoabsorbent Assay, Herpes… 1
- LIQ Enzyme Linked Immunoabsorbent Assay… 1
- GTY Antigens, All Groups, Streptococcus Spp. 1
- LFX Enzyme Linked Immunoabsorbent Assay, Rubella 1
- LGD Enzyme Linked Immunoabsorbent Assay… 1
- GQG Antigen, Cf (Including Cf Controls)… 1
- DEW Igg, Antigen, Antiserum, Control 1
- DKH Gas Chromatography, Diphenylhydantoin 1
- LAS Drug Specific Control Materials 1
- DIF Drug Mixture Control Materials 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K920661 | Vidas CMV Igg AssayLFZ · Traditional | 02/12/1993SE |
| K921302 | Vitek Immunodiagnostic Assay SystemJHI · Traditional | 07/28/1992SE |
| K921176 | Vitek Immunodiagnostic Assay SystemCEP · Traditional | 04/08/1992SE |
| K920952 | Vitek Immunodiag Assay Syst(Vidas) Ferritine AssayDBF · Traditional | 04/07/1992SE |
| K915884 | Vidas Chlamydia Assay, ModificationLJC · Traditional | 03/04/1992SE |
| K905211 | Vidas Clostridium Difficile Toxin a (Cda) AssayLLH · Traditional | 10/11/1991SE |
| K912371 | Biomerieux RSV Direct If KitLKT · Traditional | 09/23/1991SE |
| K910230 | Lyme-Spot If KitLSR · Traditional | 08/30/1991SE |
| K910210 | Slidex Meningite-Kit 5GTJ · Traditional | 08/12/1991SE |
| K910304 | Rapid Coryne Syst/Identif of Coryneform BacteriaLQL · Traditional | 07/26/1991SE |
| K911429 | Vitek Gram Negative Identification Card, ModifiedLQM · Traditional | 06/24/1991SE |
| K910499 | Immunodiagnostic Assay System Herpes Simplex VirusLGC · Traditional | 05/01/1991SE |
| K905787 | Vidas Chlamydia Assay Vitek Immundiag Assay SystLJC · Traditional | 04/29/1991SE |
| K910666 | Vitek Anaerobe Identification Card, ModificationJSP · Traditional | 04/03/1991SE |
| K895805 | Slidex Rota-Kit 2LIQ · Traditional | 02/26/1991SE |
| K905020 | Slidex Strepto-KitGTY · Traditional | 01/28/1991SE |
| K902925 | Vitek Immunodiagnostic Assay System (Vidas) (RBG)LFX · Traditional | 08/09/1990SE |
| K900996 | Vitek Anaerobe Identification CardJSP · Traditional | 05/11/1990SE |
| K900818 | Vitek Immunodiagnostic Assay System (Vidas) Toxo.LGD · Traditional | 04/30/1990SE |
| K896097 | Vidas Respiratory Syncytial Virus (RSV) AssayGQG · Traditional | 02/26/1990SE |
| K891385 | Vitek Immunodiagnostic Assay System (Vidas)DEW · Traditional | 04/18/1989SE |
| K883558 | Vitek Gram-Negative Identification CardJSS · Traditional | 09/16/1988SE |
| K883279 | Phase II FSH KitCGJ · Traditional | 09/09/1988SE |
| K882252 | Phase II LH KitCEP · Traditional | 08/04/1988SE |
| K881925 | Vitek Yeast Biochemical CardJXB · Traditional | 06/16/1988SE |
| K843686 | Ams Ana CardJSP · Traditional | 12/12/1984SE |
| K842587 | GNC PlusJTO · Traditional | 07/20/1984SE |
| K834389 | Ams Gram-Positive Ident. CardJTO · Traditional | 03/09/1984SE |
| K834269 | Ams Gram-Negative Ident. CardJTO · Traditional | 03/09/1984SE |
| K820264 | Ams Gram-Positive Identification CardJTO · Traditional | 05/03/1982SE |
| K792231 | Ams Yeast Biochemical CardJXB · Traditional | 12/19/1979SE |
| K791932 | Ams Enterobacteriacease CareJSS · Traditional | 11/13/1979SE |
| K782056 | Cord, Enterobacteriaceae BiochemicalJSS · Traditional | 01/26/1979SE |
| K780731 | Lidocaine Calibrator KitDLJ · Traditional | 01/17/1979SE |
| K780961 | Theophylline Control SerumLAS · Traditional | 12/07/1978SE |
| K780960 | Serum, Control, Drugs, AntiarrythmicDIF · Traditional | 12/07/1978SE |
| K780732 | Procainamide Calibrator KitDLJ · Traditional | 11/22/1978SE |
| K780734 | Anticonvulsants II Calibrator KitDIY · Traditional | 06/22/1978SE |
| K780733 | Anticonvulsants III Calibrator KitDKH · Traditional | 06/22/1978SE |