FDA applicant
Diazyme Laboratories
FDA records 52 decisions for Diazyme Laboratories (Poway, CA) from 2003 to 2026: 52 510(k) clearances. Most are in product codes DFH (Kappa, Antigen, Antiserum, Control) and LCP (Assay, Glycosylated Hemoglobin). Since 2016 its 510(k)s took a median of 181 days from receipt to decision, against 315 for FDA’s reviews in the same codes and years. Its devices cite 33 predicates, 9 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Diazyme Laboratories, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Diazyme Laboratories’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
1in 2008
Class I Class II/III not classified
Planning a device like Diazyme Laboratories’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