Vitek Systems, Inc.: FDA filings under this applicant name
FDA lists 39 510(k) clearances under the applicant name “Vitek Systems, Inc.” (first 1978, latest 1993), across 28 product codes in 4 review panels. Median 510(k) review time under this name: 85 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under bioMérieux, based on public ownership records.
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 |
|---|---|---|---|
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 4 | 4 |
| JSP | Kit, Anaerobic Identification | 3 | 3 |
| JSS | Kit, Identification, Enterobacteriaceae | 3 | 3 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 2 | 2 |
| DLJ | Calibrators, Drug Specific | 2 | 2 |
| JXB | Kit, Identification, Yeast | 2 | 2 |
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 2 | 2 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | 1 |
| DBF | Ferritin, Antigen, Antiserum, Control | 1 | 1 |
| DEW | Igg, Antigen, Antiserum, Control | 1 | 1 |
Plus 18 more product codes.
Review panels
- Microbiology (27)
- Clinical Toxicology (6)
- Clinical Chemistry (4)
- Immunology (2)
Most recent Vitek Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K920661 | VIDAS CMV IGG ASSAY | LFZ | 1993-02-12 | 365 |
| K921302 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | JHI | 1992-07-28 | 131 |
| K921176 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM | CEP | 1992-04-08 | 28 |
| K920952 | VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY | DBF | 1992-04-07 | 41 |
| K915884 | VIDAS CHLAMYDIA ASSAY, MODIFICATION | LJC | 1992-03-04 | 83 |
| K905211 | VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY | LLH | 1991-10-11 | 325 |
| K912371 | BIOMERIEUX RSV DIRECT IF KIT | LKT | 1991-09-23 | 117 |
| K910230 | LYME-SPOT IF KIT | LSR | 1991-08-30 | 224 |
| K910210 | SLIDEX MENINGITE-KIT 5 | GTJ | 1991-08-12 | 209 |
| K910304 | RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA | LQL | 1991-07-26 | 183 |
29 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Vitek Systems, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Vitek, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Vitek Systems, Inc.?
FDA lists 39 510(k) clearances under the applicant name “Vitek Systems, Inc.” (first 1978, latest 1993), across 28 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Vitek Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vitek Systems, Inc. is 85 days.
Which FDA product codes appear under Vitek Systems, Inc.?
The most frequent FDA product codes under this applicant name are JTO (Discs, Strips And Reagents, Microorganism Differentiation, 4); JSP (Kit, Anaerobic Identification, 3); JSS (Kit, Identification, Enterobacteriaceae, 3).
Next steps
- See all 39 Vitek Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JTO, Vitek Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.