Cleared Special

AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION

K121654 · I-Sens, Inc. · Chemistry
Sep 2012
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K121654 is an FDA 510(k) clearance for the AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by I-Sens, Inc. (Seoul, KR). The FDA issued a Cleared decision on September 5, 2012, 92 days after receiving the submission on June 5, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K121654 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 2012
Decision Date September 05, 2012
Days to Decision 92 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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