Cleared Traditional

CHEMCARD GLUCOSE TEST

K943503 · Chem-Elec, Inc. · Chemistry
Jul 1996
Decision
734d
Days
Class 2
Risk

About This 510(k) Submission

K943503 is an FDA 510(k) clearance for the CHEMCARD GLUCOSE TEST, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Chem-Elec, Inc. (North Webster, US). The FDA issued a Cleared decision on July 23, 1996, 734 days after receiving the submission on July 20, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K943503 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 1994
Decision Date July 23, 1996
Days to Decision 734 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

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

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