Vitek Systems, Inc.
Mchenry, IL, US
Vitek Systems, Inc. appears in FDA device records in Mchenry, IL. FDA records list 39 510(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
- 39
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 39 510(k) clearances for Vitek Systems, Inc. between 1978 and 1993. The busiest year on record is 1991, with 11. The most recent is 1993, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 5 |
| 1979 | 4 |
| 1982 | 1 |
| 1984 | 4 |
| 1988 | 4 |
| 1989 | 1 |
| 1990 | 4 |
| 1991 | 11 |
| 1992 | 4 |
| 1993 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K920661 | VIDAS CMV IGG ASSAY | LFZ | Substantially Equivalent | |
| K921302 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | JHI | Substantially Equivalent | |
| K921176 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | CEP | Substantially Equivalent | |
| K920952 | VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY | DBF | Substantially Equivalent | |
| K915884 | VIDAS CHLAMYDIA ASSAY, MODIFICATION | LJC | Substantially Equivalent | |
| K905211 | VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY | LLH | Substantially Equivalent | |
| K912371 | BIOMERIEUX RSV DIRECT IF KIT | LKT | Substantially Equivalent | |
| K910230 | LYME-SPOT IF KIT | LSR | Substantially Equivalent | |
| K910210 | SLIDEX MENINGITE-KIT 5 | GTJ | Substantially Equivalent | |
| K910304 | RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA | LQL | Substantially Equivalent | |
| K911429 | VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED | LQM | Substantially Equivalent | |
| K910499 | IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS | LGC | Substantially Equivalent | |
| K905787 | VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST | LJC | Substantially Equivalent | |
| K910666 | VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION | JSP | Substantially Equivalent | |
| K895805 | SLIDEX ROTA-KIT 2 | LIQ | Substantially Equivalent | |
| K905020 | SLIDEX STREPTO-KIT | GTY | Substantially Equivalent | |
| K902925 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) (RBG) | LFX | Substantially Equivalent | |
| K900996 | VITEK ANAEROBE IDENTIFICATION CARD | JSP | Substantially Equivalent | |
| K900818 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) TOXO. | LGD | Substantially Equivalent | |
| K896097 | VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY | GQG | Substantially Equivalent | |
| K891385 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) | DEW | Substantially Equivalent | |
| K883558 | VITEK GRAM-NEGATIVE IDENTIFICATION CARD | JSS | Substantially Equivalent | |
| K883279 | PHASE II FSH KIT | CGJ | Substantially Equivalent | |
| K882252 | PHASE II LH KIT | CEP | Substantially Equivalent | |
| K881925 | VITEK YEAST BIOCHEMICAL CARD | JXB | Substantially Equivalent | |
| K843686 | AMS ANA CARD | JSP | Substantially Equivalent | |
| K842587 | GNC PLUS | JTO | Substantially Equivalent | |
| K834389 | AMS GRAM-POSITIVE IDENT. CARD | JTO | Substantially Equivalent | |
| K834269 | AMS GRAM-NEGATIVE IDENT. CARD | JTO | Substantially Equivalent | |
| K820264 | AMS GRAM-POSITIVE IDENTIFICATION CARD | JTO | Substantially Equivalent | |
| K792231 | AMS YEAST BIOCHEMICAL CARD | JXB | Substantially Equivalent | |
| K791932 | AMS ENTEROBACTERIACEASE CARE | JSS | Substantially Equivalent | |
| K782056 | CORD, ENTEROBACTERIACEAE BIOCHEMICAL | JSS | Substantially Equivalent | |
| K780731 | LIDOCAINE CALIBRATOR KIT | DLJ | Substantially Equivalent | |
| K780961 | THEOPHYLLINE CONTROL SERUM | LAS | Substantially Equivalent | |
| K780960 | SERUM, CONTROL, DRUGS, ANTIARRYTHMIC | DIF | Substantially Equivalent | |
| K780732 | PROCAINAMIDE CALIBRATOR KIT | DLJ | Substantially Equivalent | |
| K780734 | ANTICONVULSANTS II CALIBRATOR KIT | DIY | Substantially Equivalent | |
| K780733 | ANTICONVULSANTS III CALIBRATOR KIT | DKH | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
- GTYAntigens, All Groups, Streptococcus Spp.
- GTJAntisera, All Groups, N. Meningitidis
- DLJCalibrators, Drug Specific
- JTODiscs, Strips And Reagents, Microorganism Differentiation
- DIFDrug Mixture Control Materials
- LASDrug Specific Control Materials
- LJCEnzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
- LFZEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus
- LGCEnzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
- LIQEnzyme Linked Immunoabsorbent Assay, Rotavirus
- LFXEnzyme Linked Immunoabsorbent Assay, Rubella
- LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
- DBFFerritin, Antigen, Antiserum, Control
- DKHGas Chromatography, Diphenylhydantoin
- DIYGas Chromatography, Ethosuximide
- LQMGram Negative Identification Panel
- LQLGram Positive Identification Panel
- DEWIgg, Antigen, Antiserum, Control
- JSPKit, Anaerobic Identification
- JSSKit, Identification, Enterobacteriaceae
- JXBKit, Identification, Yeast
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CEPRadioimmunoassay, Luteinizing Hormone
- LSRReagent, Borrelia Serological Reagent
- LLHReagents, Clostridium Difficile Toxin
- LKTRespiratory Syncytial Virus, Antigen, Antibody, Ifa
- JHIVisual, Pregnancy Hcg, Prescription Use
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