Cleared Traditional

GLUCOSITE TEST SYSTEM

K971145 · Gds Technology, LLC · Chemistry
Sep 1997
Decision
173d
Days
Class 2
Risk

About This 510(k) Submission

K971145 is an FDA 510(k) clearance for the GLUCOSITE TEST SYSTEM, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Gds Technology, LLC (Elkhart, US). The FDA issued a Cleared decision on September 17, 1997, 173 days after receiving the submission on March 28, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K971145 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 1997
Decision Date September 17, 1997
Days to Decision 173 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

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

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