510(k) Report

FDA applicant

Sensititre Microbiology A Div. of Radiometer

Westlake, OH3 decisions1991–19920 recalls

FDA records 3 decisions for Sensititre Microbiology A Div. of Radiometer (Westlake, OH) from 1991 to 1992: 3 510(k) clearances. All are in product code JWY (Manual Antimicrobial Susceptibility Test Systems). 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 Sensititre Microbiology A Div. of Radiometer’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sensititre Microbiology A Div. of Radiometer since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sensititre Microbiology A Div. of Radiometer by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Sensititre”

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