510(k) Report

FDA applicant

Toyo Jozo Co., Ltd.

Washington, DC1 decision1990–19904 recalls

FDA records 1 decision for Toyo Jozo Co., Ltd. (Washington, DC) in 1990: 1 510(k) clearance. All are in product code CHI (Lipase-Esterase, Enzymatic, Photometric, Lipase). 4 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 Toyo Jozo Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Toyo Jozo Co., Ltd. since 2007.

Recalls per year

4in 2008

2008: 4
2007high 4 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

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