FDA applicant
Biovir Laboratories, Inc.
FDA records 1 decision for Biovir Laboratories, Inc. (Benicia, CA) in 1990: 1 510(k) clearance. All are in product code KHW (Antigen, Id, Ha, Cep, Entamoeba Histolytica &…). 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 Biovir Laboratories, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Biovir Laboratories, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Biovir 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