Biotek Solutions, Inc.: FDA clearances and approvals
Biotek Solutions, Inc. has 6 FDA 510(k) clearances (first 1995, latest 1996), across 2 product codes in 1 review panel. Median 510(k) review time: 303 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 |
|---|---|---|---|
| DEH | Lambda, Antigen, Antiserum, Control | 4 | 4 |
| DFH | Kappa, Antigen, Antiserum, Control | 2 | 2 |
Review panels
- Immunology (6)
Most recent Biotek Solutions, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K950148 | CHEMMATE(TM) CD43 | DEH | 1996-07-02 | 532 |
| K936111 | CHEMMATE SPECIAL STAIN LCA-CD45 | DEH | 1996-02-27 | 796 |
| K950149 | CHEMMATE(TM) LAMBDA | DEH | 1995-12-06 | 323 |
| K950152 | CHEMMATE(TM) UCHL1 (CD45-RO) | DFH | 1995-10-27 | 283 |
| K950150 | CHEMMATE(TM) KAPPA | DFH | 1995-10-27 | 283 |
| K950151 | CHEMMATE(TM) L26 (CD20) | DEH | 1995-10-04 | 260 |
Recalls
openFDA lists no recalls under a recalling firm named Biotek Solutions, 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.
Frequently asked questions
How many FDA 510(k) clearances does Biotek Solutions, Inc. have?
Biotek Solutions, Inc. has 6 FDA 510(k) clearances (first 1995, latest 1996), across 2 product codes in 1 review panel.
How long does FDA take to clear Biotek Solutions, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Biotek Solutions, Inc.'s cleared 510(k)s is 303 days.
What devices does Biotek Solutions, Inc. make?
Its most frequent FDA product codes are DEH (Lambda, Antigen, Antiserum, Control, 4); DFH (Kappa, Antigen, Antiserum, Control, 2).
Has Biotek Solutions, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Biotek Solutions, Inc. Related entities may recall under other names.
Next steps
- See all 6 Biotek Solutions, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DEH, Biotek Solutions, 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.