Biotest Diagnostics Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Biotest Diagnostics Corp.” (first 1996, latest 1999), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 222 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| LSE | Epstein-Barr Virus, Other | 3 | 3 |
| LIN | Antisera, Conjugated Fluorescent, Cytomegalovirus | 2 | 2 |
Review panels
- Microbiology (5)
Most recent Biotest Diagnostics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K991650 | CMV BRITE TURBO KIT | LIN | 1999-07-12 | 60 |
| K983842 | BIOTEST ANTI-EBV RECOMBINANT, EA IGM | LSE | 1999-06-09 | 222 |
| K983841 | BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG | LSE | 1999-06-09 | 222 |
| K983839 | BIOTEST ANTI-EBV RECOMBINANT | LSE | 1999-06-09 | 222 |
| K951550 | CMV BRITE ANTIGENEMIA TEST KIT | LIN | 1996-01-30 | 301 |
Recalls
openFDA lists no recalls under a recalling firm named Biotest Diagnostics Corp..
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.
- Biotest Medical Corp. (10 510(k)s)
- Biotest Medizintechnik GmbH (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biotest Diagnostics Corp.?
FDA lists 5 510(k) clearances under the applicant name “Biotest Diagnostics Corp.” (first 1996, latest 1999), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Biotest Diagnostics Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biotest Diagnostics Corp. is 222 days.
Which FDA product codes appear under Biotest Diagnostics Corp.?
The most frequent FDA product codes under this applicant name are LSE (Epstein-Barr Virus, Other, 3); LIN (Antisera, Conjugated Fluorescent, Cytomegalovirus, 2).
Next steps
- See all 5 Biotest Diagnostics Corp. clearances with predicates and recalls
- Run predicate analysis for product code LSE, Biotest Diagnostics Corp.'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.