Biokit, S.A.: FDA clearances and approvals
Biokit, S.A. has 23 FDA 510(k) clearances (first 2005, latest 2025), across 16 product codes in 4 review panels. Median 510(k) review time: 159 days. Since 2017 its median was 272 days, against 140 days for all cleared 510(k)s in the same product codes. openFDA lists 1 product recall by a recalling firm named Biokit, S.A.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 2 | 196 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 190 |
| 2017 | 0 | — |
| 2018 | 2 | 94 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 2 | 530 |
| 2024 | 2 | 272 |
| 2025 | 1 | 85 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Biokit, S.A.'s cleared 510(k)s took a median 272 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 2 | 2 |
| DGC | Ige, Antigen, Antiserum, Control | 2 | 2 |
| JIT | Calibrator, Secondary | 2 | 2 |
| JZG | System, Test, Beta-2-Microglobulin Immunological | 2 | 2 |
| LEH | Radioimmunoassay, Vancomycin | 2 | 2 |
| MXJ | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | 2 | 2 |
| MYF | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | 2 | 2 |
| CEW | Radioimmunoassay, Parathyroid Hormone | 1 | 1 |
| DEM | Alpha-1-Antitrypsin, Antigen, Antiserum, Control | 1 | 1 |
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | 1 | 1 |
Plus 6 more product codes.
Review panels
- Clinical Chemistry (7)
- Immunology (6)
- Microbiology (6)
- Clinical Toxicology (4)
Most recent Biokit, S.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243575 | ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls | MYF | 2025-02-12 | 85 |
| K233606 | ADVIA Centaur EBV-VCA IgM | LSE | 2024-08-07 | 272 |
| K233605 | ADVIA Centaur EBV-EBNA IgG | LLM | 2024-08-07 | 272 |
| K213987 | ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls | MXJ | 2023-09-20 | 639 |
| K214068 | Quantia IgE | DGC | 2023-02-21 | 421 |
| K181334 | ADVIA Centaur Herpes-2 IgG | MYF | 2018-08-23 | 94 |
| K181333 | ADVIA Centaur Herpes-1 IgG | MXJ | 2018-08-23 | 94 |
| K152185 | ARCHITECT SHBG | CDZ | 2016-02-11 | 190 |
| K132400 | LP(A) CALIBRATORS, AND LP(A) CONTROLS | JIT | 2013-12-19 | 140 |
| K123947 | ARCHITECT IVANCOMYCIN | LEH | 2013-08-29 | 251 |
13 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2022-09-28.
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.
Frequently asked questions
How many FDA 510(k) clearances does Biokit, S.A. have?
Biokit, S.A. has 23 FDA 510(k) clearances (first 2005, latest 2025), across 16 product codes in 4 review panels.
How long does FDA take to clear Biokit, S.A.'s 510(k)s?
The median time from FDA receipt to decision across Biokit, S.A.'s cleared 510(k)s is 159 days. Since 2017: 272 days, versus 140 days for all cleared 510(k)s in the same product codes.
What devices does Biokit, S.A. make?
Its most frequent FDA product codes are CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone, 2); DGC (Ige, Antigen, Antiserum, Control, 2); JIT (Calibrator, Secondary, 2).
Has Biokit, S.A. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Biokit, S.A; the most recent began 2022-09-28. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 23 Biokit, S.A. clearances with predicates and recalls
- Run predicate analysis for product code CDZ, Biokit, S.A.'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.