Cleared Special

GEM Premier 3000

K161818 · Instrumentation Laboratory CO · Chemistry
Sep 2016
Decision
75d
Days
Class 2
Risk

About This 510(k) Submission

K161818 is an FDA 510(k) clearance for the GEM Premier 3000, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on September 14, 2016, 75 days after receiving the submission on July 1, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K161818 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2016
Decision Date September 14, 2016
Days to Decision 75 days
Submission Type Special
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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