Otisville Biotech, Inc.: FDA clearances and approvals
Otisville Biotech, Inc. has 98 FDA 510(k) clearances (first 1983, latest 1986), across 13 product codes in 2 review panels. Median 510(k) review time: 21 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 |
|---|---|---|---|
| JSJ | Culture Media, Selective And Non-Differential | 23 | 23 |
| JSI | Culture Media, Selective And Differential | 20 | 20 |
| JSG | Culture Media, Non-Selective And Non-Differential | 17 | 17 |
| JSH | Culture Media, Non-Selective And Differential | 9 | 9 |
| JSE | Culture Media, Multiple Biochemical Test | 7 | 7 |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 5 | 5 |
| JSF | Culture Media, Single Biochemical Test | 4 | 4 |
| KZI | Culture Media, Enriched | 4 | 4 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 2 | 2 |
| JTZ | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth | 2 | 2 |
Plus 3 more product codes.
Review panels
- Microbiology (93)
- Clinical Chemistry (2)
Most recent Otisville Biotech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K862400 | BIOTIS KV LAKED BLOOD AGAR | JSJ | 1986-07-03 | 9 |
| K862399 | BIOTIS SXT AGAR | JSJ | 1986-07-03 | 9 |
| K862398 | BIOTIS DECARBOXYLASE MEDIA, ORNITHINE | JSF | 1986-07-03 | 9 |
| K862397 | BIOTIS DECARBOXYLASE MEDIA, LYSINE | JSF | 1986-07-03 | 9 |
| K862396 | BIOTIS DECARBOXYLASE MEDIA, ARGININE | JSF | 1986-07-03 | 9 |
| K862395 | BIOTIS DECARBOXYLASE MEDIA, BASE | JSH | 1986-07-03 | 9 |
| K862394 | BIOTIS MITIS SALIVARIUS | JSI | 1986-07-03 | 9 |
| K862393 | BIOTIS LITMUS MILK | JSE | 1986-07-03 | 9 |
| K862392 | BIOTIS MOTILITY TEST MEDIUM | JSF | 1986-07-03 | 9 |
| K862391 | BIOTIS DESOXYCHOLATE AGAR | JSI | 1986-07-03 | 9 |
88 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Otisville Biotech, 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 Otisville Biotech, Inc. have?
Otisville Biotech, Inc. has 98 FDA 510(k) clearances (first 1983, latest 1986), across 13 product codes in 2 review panels.
How long does FDA take to clear Otisville Biotech, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Otisville Biotech, Inc.'s cleared 510(k)s is 21 days.
What devices does Otisville Biotech, Inc. make?
Its most frequent FDA product codes are JSJ (Culture Media, Selective And Non-Differential, 23); JSI (Culture Media, Selective And Differential, 20); JSG (Culture Media, Non-Selective And Non-Differential, 17).
Has Otisville Biotech, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Otisville Biotech, Inc. Related entities may recall under other names.
Next steps
- See all 98 Otisville Biotech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JSJ, Otisville Biotech, 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.