FDA applicant
Otisville Biopharm, Inc.
FDA records 8 decisions for Otisville Biopharm, Inc. (Otisville, NY) from 1987 to 1988: 8 510(k) clearances. Most are in product codes JSJ (Culture Media, Selective And Non-Differential) and JSF (Culture Media, Single Biochemical Test). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Otisville Biopharm, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Otisville Biopharm, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Otisville Biopharm, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Otisville”
FDA records each applicant name separately; these may or may not be the same firm.