FDA applicant

Sensititre, Ltd.

Westlake, OH3 decisions1988–19969 recalls

FDA records 3 decisions for Sensititre, Ltd. (Westlake, OH) from 1988 to 1996: 3 510(k) clearances. Most are in product codes JWY (Manual Antimicrobial Susceptibility Test Systems) and LRG (Instrument For Auto Reader & Interpretation Of…). 9 recalls are linked to its devices, 9 Class I.

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, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sensititre, Ltd. since 2007.

Recalls per year

9in 2022

2007high 9 (2022) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Sensititre, Ltd. 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.

Sensititre Microbiology A Div. of Radiometer 3 Sensititre Alamar 1

Sensititre, Ltd.

Which product codes does it file in?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Sensititre”