FDA applicant

Wako Intl., Inc.

Mchenry, IL4 decisions1978–19790 recalls

FDA records 4 decisions for Wako Intl., Inc. (Mchenry, IL) from 1978 to 1979: 4 510(k) clearances. Most are in product codes CGA (Glucose Oxidase, Glucose) and CHH (Enzymatic Esterase--Oxidase, Cholesterol). 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 Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Wako Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Wako”

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

Wako Chemicals USA, Inc. 124 Wako Pure Chemical Industries, Ltd. 6

Wako Intl., Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Wako”