Cleared Traditional

GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT

K112352 · Bionostics, Inc. · Chemistry
Dec 2011
Decision
129d
Days
Class 1
Risk

About This 510(k) Submission

K112352 is an FDA 510(k) clearance for the GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT, 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 December 23, 2011, 129 days after receiving the submission on August 16, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K112352 FDA.gov
FDA Decision Cleared SESE
Date Received August 16, 2011
Decision Date December 23, 2011
Days to Decision 129 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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