Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Biomerieux Vitek, Inc. · Predicate Candidate Screening
49 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
148 daysmedian FDA review time
479 days90th percentile
49clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K973819 | VIDAS D-DIMER (DD) ASSAY | Biomerieux Vitek, Inc. | 1998-03-10 | 154 | 0 |
| K972895 | VIDAS ROTAVIRUS (RTV) ASSAY | Biomerieux Vitek, Inc. | 1997-10-03 | 59 | 0 |
| K965092 | VIDAS ROTAVIRUS ASSAY | Biomerieux Vitek, Inc. | 1997-05-05 | 137 | 0 |
| K964887 | VIDAS C. DIFFICILE TOXIN A II ASSAY | Biomerieux Vitek, Inc. | 1997-04-08 | 123 | 0 |
| K955627 | VIDAS CHLAMYDIA BLOCKING ASSAY | Biomerieux Vitek, Inc. | 1996-10-07 | 301 | 0 |
| K962549 | VIDAS CREATINE KINASE MB ASSAY 30-421 | Biomerieux Vitek, Inc. | 1996-08-30 | 63 | 0 |
| K962609 | GRAM NEGATIVE IDENTIFICATION PLUS CARD | Biomerieux Vitek, Inc. | 1996-08-30 | 58 | 0 |
| K952095 | VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) | Biomerieux Vitek, Inc. | 1996-03-12 | 313 | 0 |
| K955647 | VIDAS ESTRADIOL II (E2II) ASSAY | Biomerieux Vitek, Inc. | 1996-02-06 | 56 | 2 |
| K943812 | VIDAS LYME SCREEN II | Biomerieux Vitek, Inc. | 1995-06-13 | 312 | 1 |
| K942049 | BIOMERIEUX HEMOLAB COFAC II | Biomerieux Vitek, Inc. | 1995-05-19 | 386 | 0 |
| K942050 | HEMOLAB COFAC IX | Biomerieux Vitek, Inc. | 1995-05-19 | 386 | 0 |
| K935850 | BIOMERIEUX HEMOLAB COFAC VII | Biomerieux Vitek, Inc. | 1995-01-17 | 405 | 0 |
| K935851 | BIOMERIEUX HEMOLAB COFAC X | Biomerieux Vitek, Inc. | 1995-01-17 | 405 | 0 |
| K931992 | HEMOLAB | Biomerieux Vitek, Inc. | 1994-12-22 | 608 | 0 |
| K934156 | BIOMERIEUX HEMOLAB AT III | Biomerieux Vitek, Inc. | 1994-12-22 | 482 | 0 |
| K934210 | HEMOLAB PROTEIN C CHROMOGENIC ASSAY | Biomerieux Vitek, Inc. | 1994-12-22 | 479 | 0 |
| K943811 | ENZYME-LINKED FLUORESCENT IMMUNOASSAY | Biomerieux Vitek, Inc. | 1994-11-02 | 89 | 0 |
| K933549 | VIDAS CMV IGM ASSAY | Biomerieux Vitek, Inc. | 1994-08-02 | 376 | 1 |
| K934274 | HEMOLAB HEPARICHROM ASSAY | Biomerieux Vitek, Inc. | 1994-05-06 | 248 | 0 |
| K925493 | BIOMERIEUX HEMOLAB THROMBICALCI-TEST | Biomerieux Vitek, Inc. | 1994-04-21 | 535 | 0 |
| K930267 | BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL | Biomerieux Vitek, Inc. | 1994-03-22 | 427 | 0 |
| K934764 | VIDAS T3 ASSAY | Biomerieux Vitek, Inc. | 1994-03-22 | 169 | 0 |
| K935816 | VIDAS T UPTAKE | Biomerieux Vitek, Inc. | 1994-03-22 | 110 | 0 |
| K921989 | FDP - SLIDEX DIRECT | Biomerieux Vitek, Inc. | 1993-11-03 | 554 | 0 |
| K933010 | BIOMERIEUX HEMOLAB COFAC VIII | Biomerieux Vitek, Inc. | 1993-09-15 | 86 | 0 |
| K932250 | VIDAS DIGOXIN (DIG) | Biomerieux Vitek, Inc. | 1993-09-10 | 123 | 0 |
| K933258 | VIDAS THEOPHYLLINE(THEO) | Biomerieux Vitek, Inc. | 1993-08-16 | 41 | 0 |
| K923903 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA | Biomerieux Vitek, Inc. | 1993-08-09 | 370 | 0 |
| K931031 | VIDAS CORTISOL (CORT) ASSAY & SERUM FREE DILUTENT | Biomerieux Vitek, Inc. | 1993-07-27 | 148 | 0 |
| K931334 | VIDAS TOXO COMPETITION (TXC) ASSAY | Biomerieux Vitek, Inc. | 1993-06-21 | 97 | 0 |
| K931224 | VIDAS TOTAL IGE (IGE) ASSAY | Biomerieux Vitek, Inc. | 1993-05-20 | 71 | 0 |
| K925494 | BIOMERIEUX HEMOLAB FIBRINOMAT | Biomerieux Vitek, Inc. | 1993-05-18 | 197 | 0 |
| K926393 | VIDAS THYROXINE (T4) ASSAY (T4) | Biomerieux Vitek, Inc. | 1993-05-13 | 143 | 0 |
| K922737 | VIDAS TOXO IG6 ASSAY (TX6) | Biomerieux Vitek, Inc. | 1993-05-11 | 337 | 0 |
| K925915 | VITEK RAPID CALL-GRAM NEGATIV IDENT CARD | Biomerieux Vitek, Inc. | 1993-03-23 | 120 | 0 |
| K925916 | VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD | Biomerieux Vitek, Inc. | 1993-03-23 | 120 | 0 |
| K923166 | VIDAS TOXOPLASMA GONDII IGM ASSSAY | Biomerieux Vitek, Inc. | 1993-02-25 | 241 | 0 |
| K923579 | MINIVIDAS INSTRUMENT | Biomerieux Vitek, Inc. | 1993-02-12 | 207 | 2 |
| K925498 | VIDAS ESTRADIOL (E2) ASSAY | Biomerieux Vitek, Inc. | 1993-02-12 | 105 | 0 |
| K924218 | BAC-T-SCREEN | Biomerieux Vitek, Inc. | 1993-02-03 | 167 | 0 |
| K925492 | BIOMERIEUX HEMOLAB THROMBOMAT | Biomerieux Vitek, Inc. | 1993-02-03 | 93 | 0 |
| K925177 | VIDAS FREE THYROXINE(FT4) ASSAY | Biomerieux Vitek, Inc. | 1992-11-30 | 47 | 0 |
| K923122 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | Biomerieux Vitek, Inc. | 1992-10-26 | 122 | 1 |
| K922768 | RAPID NFT, MODIFICATION | Biomerieux Vitek, Inc. | 1992-10-14 | 128 | 0 |
| K923212 | SLIDEX STAPH-KIT | Biomerieux Vitek, Inc. | 1992-09-28 | 89 | 1 |
| K920001 | HEMOLAB SILIMAT REAGENT | Biomerieux Vitek, Inc. | 1992-09-25 | 267 | 0 |
| K921816 | VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAY | Biomerieux Vitek, Inc. | 1992-06-18 | 64 | 0 |
| K921746 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | Biomerieux Vitek, Inc. | 1992-06-16 | 64 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda