Cleared Traditional

WAKO GLUCOSE C

K842221 · Wako Pure Chemical Industries, Ltd. · Chemistry
Jul 1984
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K842221 is an FDA 510(k) clearance for the WAKO GLUCOSE C, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Wako Pure Chemical Industries, Ltd. (Mchenry, US). The FDA issued a Cleared decision on July 12, 1984, 37 days after receiving the submission on June 5, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K842221 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 1984
Decision Date July 12, 1984
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CGA — Glucose Oxidase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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