510(k) Report

FDA applicant

Wako Pure Chemical Industries, Ltd.

Mchenry, IL6 decisions1979–19840 recalls

FDA records 6 decisions for Wako Pure Chemical Industries, Ltd. (Mchenry, IL) from 1979 to 1984: 6 510(k) clearances. Most are in product codes CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme…) and CEL (Ammonium Molybdate And Ammonium Vanadate…). No recall is 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 Wako Pure Chemical Industries, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Wako Pure Chemical Industries, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Wako Pure Chemical Industries, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Wako Pure Chemical Industries, Ltd.’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 “Wako”

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