510(k) Report

FDA applicant

Tosoh Corp.

Washington, D.C., DC11 decisions1990–20023 recalls

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, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

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

2018: 3
2007high 3 (2018) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Tosoh Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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Other applicant names beginning “Tosoh”

FDA records each applicant name separately; these may or may not be the same firm.