FDA applicant
Pasco Laboratories, Inc.
FDA records 67 decisions for Pasco Laboratories, Inc. (Wheat Ridge, CO) from 1978 to 2004: 66 510(k) clearances and 1 original PMA approval. Most are in product codes JWY (Manual Antimicrobial Susceptibility Test Systems) and JTN (Susceptibility Test Discs, Antimicrobial). Its devices cite 65 predicates, 63 of them its own earlier devices. 8 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Pasco Laboratories, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Pasco Laboratories, Inc. since 2007.
Recalls per year
8in 2008
Class I Class II/III not classified
Planning a device like Pasco Laboratories, 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