Cleared Traditional

GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK

K081403 · Bionostics, Inc. · Chemistry
Jul 2008
Decision
67d
Days
Class 1
Risk

About This 510(k) Submission

K081403 is an FDA 510(k) clearance for the GLUCOSE METER-CHECK CONTROL 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 July 25, 2008, 67 days after receiving the submission on May 19, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K081403 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 2008
Decision Date July 25, 2008
Days to Decision 67 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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