510(k) Report

FDA applicant

Culture Kits, Inc.

Norwich, NY9 decisions1985–19910 recalls

FDA records 9 decisions for Culture Kits, Inc. (Norwich, NY) from 1985 to 1991: 9 510(k) clearances. Most are in product codes JSI (Culture Media, Selective And Differential) and JTZ (Culture Media, Antimicrobial Susceptibility…). 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 Culture Kits, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Culture Kits, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Culture Kits, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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