Otisville Biopharm, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Otisville Biopharm, Inc.” (first 1987, latest 1988), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 52 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 |
|---|---|---|---|
| JSJ | Culture Media, Selective And Non-Differential | 4 | 4 |
| JSF | Culture Media, Single Biochemical Test | 2 | 2 |
| KZI | Culture Media, Enriched | 2 | 2 |
Review panels
- Microbiology (8)
Most recent Otisville Biopharm, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K874176 | BIOTIS (TM) HAEMOPHILUS DUCREYI | JSJ | 1988-02-05 | 115 |
| K874179 | BIOTIS (TM) SABHI (DOUBLE POUR) | KZI | 1988-01-28 | 107 |
| K874178 | BIOTIS (TM) BCYE SELECTIVE | JSJ | 1987-12-04 | 52 |
| K874177 | BIOTIS (TM) BCYE | KZI | 1987-12-04 | 50 |
| K874175 | BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC | JSF | 1987-12-04 | 52 |
| K874174 | BIOTIS (TM) STARCH HYDROLYSIS WITH BCP | JSF | 1987-12-04 | 52 |
| K874173 | BIOTIS (TM) BHI WITH HRBC, CHLORA/GENTAM/CYCLOHEXI | JSJ | 1987-10-28 | 15 |
| K874172 | BIOTIS (TM) INHIBITORY MOLD AGAR (DOUBLE POUR) | JSJ | 1987-10-28 | 15 |
Recalls
openFDA lists no recalls under a recalling firm named Otisville Biopharm, 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.
- Otisville Biotech, Inc. (98 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Otisville Biopharm, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Otisville Biopharm, Inc.” (first 1987, latest 1988), 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 Otisville Biopharm, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Otisville Biopharm, Inc. is 52 days.
Which FDA product codes appear under Otisville Biopharm, Inc.?
The most frequent FDA product codes under this applicant name are JSJ (Culture Media, Selective And Non-Differential, 4); JSF (Culture Media, Single Biochemical Test, 2); KZI (Culture Media, Enriched, 2).
Next steps
- See all 8 Otisville Biopharm, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JSJ, Otisville Biopharm, 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.