Cleared Traditional

GLUCOSE OXIDASE RATE REAGENT

K811165 · Chem-Elec, Inc. · Chemistry
Aug 1981
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K811165 is an FDA 510(k) clearance for the GLUCOSE OXIDASE RATE REAGENT, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Chem-Elec, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 13, 1981, 107 days after receiving the submission on April 28, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K811165 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 1981
Decision Date August 13, 1981
Days to Decision 107 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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