510(k) Report

FDA applicant

Otisville Biotech, Inc.

Otisville, NY98 decisions1983–19860 recalls

FDA records 98 decisions for Otisville Biotech, Inc. (Otisville, NY) from 1983 to 1986: 98 510(k) clearances. Most are in product codes JSJ (Culture Media, Selective And Non-Differential) and JSI (Culture Media, Selective And Differential). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, microbiology panel, where it files most

How often FDA has decided Otisville Biotech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Otisville Biotech, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Otisville Biotech, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Otisville”

FDA records each applicant name separately; these may or may not be the same firm.