Cleared Traditional

FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE

K133197 · Fujirebio Diagnostics,Inc. · Chemistry
Jan 2014
Decision
92d
Days
Class 1
Risk

About This 510(k) Submission

K133197 is an FDA 510(k) clearance for the FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE, 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, 2014, 92 days after receiving the submission on October 17, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K133197 FDA.gov
FDA Decision Cleared SESE
Date Received October 17, 2013
Decision Date January 17, 2014
Days to Decision 92 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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