Cleared Traditional

GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002

K082395 · Bionostics, Inc. · Chemistry
Sep 2008
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K082395 is an FDA 510(k) clearance for the GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Bionostics, Inc. (Devens, US). The FDA issued a Cleared decision on September 18, 2008, 30 days after receiving the submission on August 19, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K082395 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 2008
Decision Date September 18, 2008
Days to Decision 30 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJX — Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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