Biomerieux Vitek, Inc.: FDA clearances and approvals
Biomerieux Vitek, Inc. has 49 FDA 510(k) clearances (first 1992, latest 1998), plus 1 PMA decision, across 41 product codes in 6 review panels. Median 510(k) review time: 148 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GJT | Plasma, Coagulation Factor Deficient | 5 | 5 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 3 | 3 |
| CHP | Radioimmunoassay, Estradiol | 2 | 2 |
| LIQ | Enzyme Linked Immunoabsorbent Assay, Rotavirus | 2 | 2 |
| LQL | Gram Positive Identification Panel | 2 | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 | 1 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | 1 |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 1 | 1 |
Plus 31 more product codes.
Review panels
- Microbiology (19)
- Hematology (15)
- Clinical Chemistry (12)
- Clinical Toxicology (2)
- Immunology (1)
- General and Plastic Surgery (1)
Most recent Biomerieux Vitek, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973819 | VIDAS D-DIMER (DD) ASSAY | DAP | 1998-03-10 | 154 |
| K972895 | VIDAS ROTAVIRUS (RTV) ASSAY | LIQ | 1997-10-03 | 59 |
| K965092 | VIDAS ROTAVIRUS ASSAY | LIQ | 1997-05-05 | 137 |
| K964887 | VIDAS C. DIFFICILE TOXIN A II ASSAY | LLH | 1997-04-08 | 123 |
| K955627 | VIDAS CHLAMYDIA BLOCKING ASSAY | LJC | 1996-10-07 | 301 |
| K962609 | GRAM NEGATIVE IDENTIFICATION PLUS CARD | LRH | 1996-08-30 | 58 |
| K962549 | VIDAS CREATINE KINASE MB ASSAY 30-421 | JHX | 1996-08-30 | 63 |
| K952095 | VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) | LQL | 1996-03-12 | 313 |
| K955647 | VIDAS ESTRADIOL II (E2II) ASSAY | CHP | 1996-02-06 | 56 |
| K943812 | VIDAS LYME SCREEN II | LSR | 1995-06-13 | 312 |
39 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| N50510 | PMA | VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD | 1978-03-02 |
Recalls
openFDA lists no recalls under a recalling firm named Biomerieux Vitek, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Biomerieux Vitek, Inc.'s product codes (a text match, not an official crosswalk):
- J7197 — Antithrombin iii (human), per i.u. (via JBQ)
- J7213 — Injection, coagulation factor ix (recombinant), ixinity, 1 i.u. (via GJT)
Frequently asked questions
How many FDA 510(k) clearances does Biomerieux Vitek, Inc. have?
Biomerieux Vitek, Inc. has 49 FDA 510(k) clearances (first 1992, latest 1998), plus 1 PMA decision, across 41 product codes in 6 review panels.
How long does FDA take to clear Biomerieux Vitek, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Biomerieux Vitek, Inc.'s cleared 510(k)s is 148 days.
What devices does Biomerieux Vitek, Inc. make?
Its most frequent FDA product codes are GJT (Plasma, Coagulation Factor Deficient, 5); LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii, 3); CHP (Radioimmunoassay, Estradiol, 2).
Has Biomerieux Vitek, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Biomerieux Vitek, Inc. Related entities may recall under other names.
Next steps
- See all 49 Biomerieux Vitek, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GJT, Biomerieux Vitek, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.