FDA applicant
Kev Connecticut Diagnostics, Inc.
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
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.
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.
See the 510(k) Report