FDA applicant
Bio-Rad Laboratories, Inc.
FDA records 132 decisions for Bio-Rad Laboratories, Inc. (Chaska, MN) from 1984 to 2019: 127 510(k) clearances, 1 De Novo grant and 4 original PMA approvals. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and LCP (Assay, Glycosylated Hemoglobin). Its devices cite 121 predicates, 27 of them its own earlier devices. 76 recalls are linked to its devices.
FDA’s records also spell it “Bio-Rad Laboratories”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Bio-Rad Laboratories, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2019
2026 so far, outlined.
Recalls per year
2in 2025
Class I Class II/III not classified
Planning a device like Bio-Rad 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