Bioquest: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Bioquest” (first 1976, latest 1976), plus 1 PMA decision, across 3 product codes in 1 review panel. Median 510(k) review time under this name: 14 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 |
|---|---|---|---|
| JSG | Culture Media, Non-Selective And Non-Differential | 1 | 1 |
| JSX | Kit, Identification, Neisseria Gonorrhoeae | 1 | 0 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 1 | 1 |
Review panels
- Microbiology (3)
Most recent Bioquest 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K761209 | TAXO DISCS FOR DIFF. OF ANAEROBES | JTO | 1976-12-09 | 2 |
| K760764 | YEAST ASSIMILATION AGAR | JSG | 1976-10-29 | 25 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P770002 | PMA | GONOCOCCAL PILI ANTIBODY TEST | 1979-07-18 |
Recalls
openFDA lists no recalls under a recalling firm named Bioquest.
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.
SEC filings
Bioquest Corp (BQST): EDGAR filings, CIK 1568628. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Bioquest?
FDA lists 2 510(k) clearances under the applicant name “Bioquest” (first 1976, latest 1976), plus 1 PMA decision, across 3 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 Bioquest?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bioquest is 14 days.
Which FDA product codes appear under Bioquest?
The most frequent FDA product codes under this applicant name are JSG (Culture Media, Non-Selective And Non-Differential, 1); JSX (Kit, Identification, Neisseria Gonorrhoeae, 1); JTO (Discs, Strips And Reagents, Microorganism Differentiation, 1).
Next steps
- See all 2 Bioquest clearances with predicates and recalls
- Run predicate analysis for product code JSG, Bioquest'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.