Cleared Traditional

GLUCOSE ENZYME-COLOR REAGENT SET

K813412 · Diagnostic Specialties · Chemistry
Dec 1981
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K813412 is an FDA 510(k) clearance for the GLUCOSE ENZYME-COLOR REAGENT SET, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Diagnostic Specialties (Mchenry, US). The FDA issued a Cleared decision on December 31, 1981, 27 days after receiving the submission on December 4, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K813412 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 1981
Decision Date December 31, 1981
Days to Decision 27 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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