FDA applicant
Tosoh Corp.
FDA records 11 decisions for Tosoh Corp. (Washington, D.C., DC) from 1990 to 2002: 11 510(k) clearances. Most are in product codes KHO (Fluorometer, For Clinical Use) and NIG (System, Test, Carbohydrate Antigen (Ca19-9)…). 3 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 Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Tosoh Corp. since 2007.
Recalls per year
3in 2018
Class I Class II/III not classified
Planning a device like Tosoh Corp.’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.