Cleared Traditional

GLUCOSE(ENZYMATIC) REAGENT SET

K821204 · Omega Medical Electronics · Chemistry
Jul 1982
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K821204 is an FDA 510(k) clearance for the GLUCOSE(ENZYMATIC) REAGENT SET, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Omega Medical Electronics (Mchenry, US). The FDA issued a Cleared decision on July 22, 1982, 86 days after receiving the submission on April 27, 1982. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K821204 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 1982
Decision Date July 22, 1982
Days to Decision 86 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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