Cleared Traditional

FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA

K123612 · Fujirebio Diagnostics,Inc. · Chemistry
Jan 2013
Decision
55d
Days
Class 1
Risk

About This 510(k) Submission

K123612 is an FDA 510(k) clearance for the FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Fujirebio Diagnostics,Inc. (Seguin, US). The FDA issued a Cleared decision on January 17, 2013, 55 days after receiving the submission on November 23, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K123612 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 2012
Decision Date January 17, 2013
Days to Decision 55 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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