510(k) Report

FDA applicant

Kev Connecticut Diagnostics, Inc.

Danielson, CT2 decisions1991–19910 recalls

FDA records 2 decisions for Kev Connecticut Diagnostics, Inc. (Danielson, CT) in 1991: 2 510(k) clearances. Most are in product codes JSX (Kit, Identification, Neisseria Gonorrhoeae) and LQL (Gram Positive Identification Panel). 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 Kev Connecticut Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Kev Connecticut Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Kev Connecticut Diagnostics, 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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