Company ยท US
Biomerieux Vitek, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 1998. Name variants (Inc, Corp, punctuation) are merged.
49510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GJT | Plasma, Coagulation Factor Deficient | 5 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 3 |
| CHP | Radioimmunoassay, Estradiol | 2 |
| LIQ | Enzyme Linked Immunoabsorbent Assay, Rotavirus | 2 |
| LQL | Gram Positive Identification Panel | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 1 |
| DGP | Ige, Fitc, Antigen, Antiserum, Control | 1 |
| GFI | Osteotome, Manual | 1 |
| GGC | Control, Plasma, Abnormal | 1 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 1 |
| GHH | Fibrin Split Products | 1 |
| GIS | Test, Fibrinogen | 1 |
| GJA | Test, Thrombin Time | 1 |
| GJS | Test, Time, Prothrombin | 1 |
| GKP | Instrument, Coagulation, Automated | 1 |
| JBQ | Antithrombin Iii Quantitation | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 10, 1998 | K973819 | VIDAS D-DIMER (DD) ASSAY Biomerieux Vitek, Inc. | DAP |
| Oct 3, 1997 | K972895 | VIDAS ROTAVIRUS (RTV) ASSAY Biomerieux Vitek, Inc. | LIQ |
| May 5, 1997 | K965092 | VIDAS ROTAVIRUS ASSAY Biomerieux Vitek, Inc. | LIQ |
| Apr 8, 1997 | K964887 | VIDAS C. DIFFICILE TOXIN A II ASSAY Biomerieux Vitek, Inc. | LLH |
| Oct 7, 1996 | K955627 | VIDAS CHLAMYDIA BLOCKING ASSAY Biomerieux Vitek, Inc. | LJC |
| Aug 30, 1996 | K962609 | GRAM NEGATIVE IDENTIFICATION PLUS CARD Biomerieux Vitek, Inc. | LRH |
| Aug 30, 1996 | K962549 | VIDAS CREATINE KINASE MB ASSAY 30-421 Biomerieux Vitek, Inc. | JHX |
| Mar 12, 1996 | K952095 | VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) Biomerieux Vitek, Inc. | LQL |
| Feb 6, 1996 | K955647 | VIDAS ESTRADIOL II (E2II) ASSAY Biomerieux Vitek, Inc. | CHP |
| Jun 13, 1995 | K943812 | VIDAS LYME SCREEN II Biomerieux Vitek, Inc. | LSR |
| May 19, 1995 | K942050 | HEMOLAB COFAC IX Biomerieux Vitek, Inc. | GJT |
| May 19, 1995 | K942049 | BIOMERIEUX HEMOLAB COFAC II Biomerieux Vitek, Inc. | GJT |
| Jan 17, 1995 | K935851 | BIOMERIEUX HEMOLAB COFAC X Biomerieux Vitek, Inc. | GJT |
| Jan 17, 1995 | K935850 | BIOMERIEUX HEMOLAB COFAC VII Biomerieux Vitek, Inc. | GJT |
| Dec 22, 1994 | K934210 | HEMOLAB PROTEIN C CHROMOGENIC ASSAY Biomerieux Vitek, Inc. | GGP |
| Dec 22, 1994 | K934156 | BIOMERIEUX HEMOLAB AT III Biomerieux Vitek, Inc. | JBQ |
| Dec 22, 1994 | K931992 | HEMOLAB Biomerieux Vitek, Inc. | GKP |
| Nov 2, 1994 | K943811 | ENZYME-LINKED FLUORESCENT IMMUNOASSAY Biomerieux Vitek, Inc. | CFT |
| Aug 2, 1994 | K933549 | VIDAS CMV IGM ASSAY Biomerieux Vitek, Inc. | LKQ |
| May 6, 1994 | K934274 | HEMOLAB HEPARICHROM ASSAY Biomerieux Vitek, Inc. | KFF |
| Apr 21, 1994 | K925493 | BIOMERIEUX HEMOLAB THROMBICALCI-TEST Biomerieux Vitek, Inc. | GJA |
| Mar 22, 1994 | K935816 | VIDAS T UPTAKE Biomerieux Vitek, Inc. | KHQ |
| Mar 22, 1994 | K934764 | VIDAS T3 ASSAY Biomerieux Vitek, Inc. | CDP |
| Mar 22, 1994 | K930267 | BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL Biomerieux Vitek, Inc. | GGC |
| Nov 3, 1993 | K921989 | FDP - SLIDEX DIRECT Biomerieux Vitek, Inc. | GHH |
| Sep 15, 1993 | K933010 | BIOMERIEUX HEMOLAB COFAC VIII Biomerieux Vitek, Inc. | GJT |
| Sep 10, 1993 | K932250 | VIDAS DIGOXIN (DIG) Biomerieux Vitek, Inc. | KXT |
| Aug 16, 1993 | K933258 | VIDAS THEOPHYLLINE(THEO) Biomerieux Vitek, Inc. | KLS |
| Aug 9, 1993 | K923903 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA Biomerieux Vitek, Inc. | LJY |
| Jul 27, 1993 | K931031 | VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT Biomerieux Vitek, Inc. | JFT |
| Jun 21, 1993 | K931334 | VIDAS TOXO COMPETITION (TXC) ASSAY Biomerieux Vitek, Inc. | LGD |
| May 20, 1993 | K931224 | VIDAS TOTAL IGE (IGE) ASSAY Biomerieux Vitek, Inc. | DGP |
| May 18, 1993 | K925494 | BIOMERIEUX HEMOLAB FIBRINOMAT Biomerieux Vitek, Inc. | GIS |
| May 13, 1993 | K926393 | VIDAS THYROXINE (T4) ASSAY (T4) Biomerieux Vitek, Inc. | KLI |
| May 11, 1993 | K922737 | VIDAS TOXO IG6 ASSAY (TX6) Biomerieux Vitek, Inc. | LGD |
| Mar 23, 1993 | K925916 | VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD Biomerieux Vitek, Inc. | LQL |
| Mar 23, 1993 | K925915 | VITEK RAPID CALL-GRAM NEGATIV IDENT CARD Biomerieux Vitek, Inc. | LQM |
| Feb 25, 1993 | K923166 | VIDAS TOXOPLASMA GONDII IGM ASSSAY Biomerieux Vitek, Inc. | LGD |
| Feb 12, 1993 | K925498 | VIDAS ESTRADIOL (E2) ASSAY Biomerieux Vitek, Inc. | CHP |
| Feb 12, 1993 | K923579 | MINIVIDAS INSTRUMENT Biomerieux Vitek, Inc. | JJE |
| Feb 3, 1993 | K925492 | BIOMERIEUX HEMOLAB THROMBOMAT Biomerieux Vitek, Inc. | GJS |
| Feb 3, 1993 | K924218 | BAC-T-SCREEN Biomerieux Vitek, Inc. | JXA |
| Nov 30, 1992 | K925177 | VIDAS FREE THYROXINE(FT4) ASSAY Biomerieux Vitek, Inc. | CEC |
| Oct 26, 1992 | K923122 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM Biomerieux Vitek, Inc. | LFY |
| Oct 14, 1992 | K922768 | RAPID NFT, MODIFICATION Biomerieux Vitek, Inc. | JSW |
| Sep 28, 1992 | K923212 | SLIDEX STAPH-KIT Biomerieux Vitek, Inc. | JWX |
| Sep 25, 1992 | K920001 | HEMOLAB SILIMAT REAGENT Biomerieux Vitek, Inc. | GFI |
| Jun 18, 1992 | K921816 | VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAY Biomerieux Vitek, Inc. | JLW |
| Jun 16, 1992 | K921746 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM Biomerieux Vitek, Inc. | CGJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||