Cleared Traditional

GLUCOSE METER-CHECK SOLUTION FOR BAYER

K123966 · Bionostics, Inc. · Chemistry
Jan 2013
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K123966 is an FDA 510(k) clearance for the GLUCOSE METER-CHECK SOLUTION FOR BAYER, 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 January 25, 2013, 30 days after receiving the submission on December 26, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K123966 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2012
Decision Date January 25, 2013
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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