Cleared Traditional

GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK

K123851 · Bionostics, Inc. · Chemistry
Feb 2013
Decision
62d
Days
Class 1
Risk

About This 510(k) Submission

K123851 is an FDA 510(k) clearance for the GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK, 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 February 14, 2013, 62 days after receiving the submission on December 14, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K123851 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 2012
Decision Date February 14, 2013
Days to Decision 62 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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