FDA applicant
Tosoh Medics, Inc.
FDA records 41 decisions for Tosoh Medics, Inc. (South San Francisco, CA) from 1990 to 2002: 41 510(k) clearances. Most are in product codes JJX (Single (Specified) Analyte Controls (Assayed…) and CDP (Radioimmunoassay, Total Triiodothyronine). Its devices cite 6 predicates, 2 of them its own earlier devices. 26 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 Medics, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Tosoh Medics, Inc. since 2007.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Tosoh Medics, 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”
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