Company ยท US
Vitek Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 1993. Name variants (Inc, Corp, punctuation) are merged.
39510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 4 |
| JSP | Kit, Anaerobic Identification | 3 |
| JSS | Kit, Identification, Enterobacteriaceae | 3 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 2 |
| DLJ | Calibrators, Drug Specific | 2 |
| JXB | Kit, Identification, Yeast | 2 |
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 2 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 |
| DBF | Ferritin, Antigen, Antiserum, Control | 1 |
| DEW | Igg, Antigen, Antiserum, Control | 1 |
| DIF | Drug Mixture Control Materials | 1 |
| DIY | Gas Chromatography, Ethosuximide | 1 |
| DKH | Gas Chromatography, Diphenylhydantoin | 1 |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | 1 |
| GTJ | Antisera, All Groups, N. Meningitidis | 1 |
| GTY | Antigens, All Groups, Streptococcus Spp. | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 |
| LAS | Drug Specific Control Materials | 1 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 1 |
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 12, 1993 | K920661 | VIDAS CMV IGG ASSAY Vitek Systems, Inc. | LFZ |
| Jul 28, 1992 | K921302 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM Vitek Systems, Inc. | JHI |
| Apr 8, 1992 | K921176 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM Vitek Systems, Inc. | CEP |
| Apr 7, 1992 | K920952 | VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY Vitek Systems, Inc. | DBF |
| Mar 4, 1992 | K915884 | VIDAS CHLAMYDIA ASSAY, MODIFICATION Vitek Systems, Inc. | LJC |
| Oct 11, 1991 | K905211 | VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY Vitek Systems, Inc. | LLH |
| Sep 23, 1991 | K912371 | BIOMERIEUX RSV DIRECT IF KIT Vitek Systems, Inc. | LKT |
| Aug 30, 1991 | K910230 | LYME-SPOT IF KIT Vitek Systems, Inc. | LSR |
| Aug 12, 1991 | K910210 | SLIDEX MENINGITE-KIT 5 Vitek Systems, Inc. | GTJ |
| Jul 26, 1991 | K910304 | RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA Vitek Systems, Inc. | LQL |
| Jun 24, 1991 | K911429 | VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED Vitek Systems, Inc. | LQM |
| May 1, 1991 | K910499 | IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS Vitek Systems, Inc. | LGC |
| Apr 29, 1991 | K905787 | VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST Vitek Systems, Inc. | LJC |
| Apr 3, 1991 | K910666 | VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION Vitek Systems, Inc. | JSP |
| Feb 26, 1991 | K895805 | SLIDEX ROTA-KIT 2 Vitek Systems, Inc. | LIQ |
| Jan 28, 1991 | K905020 | SLIDEX STREPTO-KIT Vitek Systems, Inc. | GTY |
| Aug 9, 1990 | K902925 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) (RBG) Vitek Systems, Inc. | LFX |
| May 11, 1990 | K900996 | VITEK ANAEROBE IDENTIFICATION CARD Vitek Systems, Inc. | JSP |
| Apr 30, 1990 | K900818 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) TOXO. Vitek Systems, Inc. | LGD |
| Feb 26, 1990 | K896097 | VIDAS RESPIRATORY SYNCYTIAL VIRUS (RSV) ASSAY Vitek Systems, Inc. | GQG |
| Apr 18, 1989 | K891385 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) Vitek Systems, Inc. | DEW |
| Sep 16, 1988 | K883558 | VITEK GRAM-NEGATIVE IDENTIFICATION CARD Vitek Systems, Inc. | JSS |
| Sep 9, 1988 | K883279 | PHASE II FSH KIT Vitek Systems, Inc. | CGJ |
| Aug 4, 1988 | K882252 | PHASE II LH KIT Vitek Systems, Inc. | CEP |
| Jun 16, 1988 | K881925 | VITEK YEAST BIOCHEMICAL CARD Vitek Systems, Inc. | JXB |
| Dec 12, 1984 | K843686 | AMS ANA CARD Vitek Systems, Inc. | JSP |
| Jul 20, 1984 | K842587 | GNC PLUS Vitek Systems, Inc. | JTO |
| Mar 9, 1984 | K834389 | AMS GRAM-POSITIVE IDENT. CARD Vitek Systems, Inc. | JTO |
| Mar 9, 1984 | K834269 | AMS GRAM-NEGATIVE IDENT. CARD Vitek Systems, Inc. | JTO |
| May 3, 1982 | K820264 | AMS GRAM-POSITIVE IDENTIFICATION CARD Vitek Systems, Inc. | JTO |
| Dec 19, 1979 | K792231 | AMS YEAST BIOCHEMICAL CARD Vitek Systems, Inc. | JXB |
| Nov 13, 1979 | K791932 | AMS ENTEROBACTERIACEASE CARE Vitek Systems, Inc. | JSS |
| Jan 26, 1979 | K782056 | CORD, ENTEROBACTERIACEAE BIOCHEMICAL Vitek Systems, Inc. | JSS |
| Jan 17, 1979 | K780731 | LIDOCAINE CALIBRATOR KIT Vitek Systems, Inc. | DLJ |
| Dec 7, 1978 | K780961 | THEOPHYLLINE CONTROL SERUM Vitek Systems, Inc. | LAS |
| Dec 7, 1978 | K780960 | SERUM, CONTROL, DRUGS, ANTIARRYTHMIC Vitek Systems, Inc. | DIF |
| Nov 22, 1978 | K780732 | PROCAINAMIDE CALIBRATOR KIT Vitek Systems, Inc. | DLJ |
| Jun 22, 1978 | K780734 | ANTICONVULSANTS II CALIBRATOR KIT Vitek Systems, Inc. | DIY |
| Jun 22, 1978 | K780733 | ANTICONVULSANTS III CALIBRATOR KIT Vitek Systems, Inc. | DKH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||