Cleared Traditional

GLUCOSE METER-CHECK SOLUTION FOR TAIDOC

K131136 · Bionostics, Inc. · Chemistry
May 2013
Decision
39d
Days
Class 1
Risk

About This 510(k) Submission

K131136 is an FDA 510(k) clearance for the GLUCOSE METER-CHECK SOLUTION FOR TAIDOC, 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 May 31, 2013, 39 days after receiving the submission on April 22, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K131136 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 2013
Decision Date May 31, 2013
Days to Decision 39 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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