FDA applicant
Tosoh Bioscience, Inc.
FDA records 21 decisions for Tosoh Bioscience, Inc. (South San Franciso, CA) from 1993 to 2025: 20 510(k) clearances and 1 original PMA approval. Most are in product codes JIT (Calibrator, Secondary) and PDJ (Hemoglobin A1c Test System). Its devices cite 18 predicates, 3 of them its own earlier devices. 13 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Tosoh Bioscience, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
11in 2018
Class I Class II/III not classified
Planning a device like Tosoh Bioscience, 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) ReportOther applicant names beginning “Tosoh”
FDA records each applicant name separately; these may or may not be the same firm.