FDA applicant
Biogenex Laboratories
FDA records 13 decisions for Biogenex Laboratories (San Ramon, CA) from 1981 to 2004: 12 510(k) clearances and 1 original PMA approval. Most are in product codes JHI (Visual, Pregnancy Hcg, Prescription Use) and CEP (Radioimmunoassay, Luteinizing Hormone). Its devices cite 2 predicates, 0 of them its own earlier devices. 4 recalls are linked to its devices.
FDA’s records also spell it “Biogenex Laboratories, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Biogenex Laboratories’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Biogenex Laboratories since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Biogenex 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