Cleared Traditional

GLUCOSE METER-CHECK SOLUTION FOR INFOPIA

K113764 · Bionostics, Inc. · Chemistry
Jan 2012
Decision
40d
Days
Class 1
Risk

About This 510(k) Submission

K113764 is an FDA 510(k) clearance for the GLUCOSE METER-CHECK SOLUTION FOR INFOPIA, 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 30, 2012, 40 days after receiving the submission on December 21, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K113764 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2011
Decision Date January 30, 2012
Days to Decision 40 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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