Cleared Traditional

LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK

K140916 · Bio-Rad Laboratories · Chemistry
May 2014
Decision
26d
Days
Class 1
Risk

About This 510(k) Submission

K140916 is an FDA 510(k) clearance for the LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Bio-Rad Laboratories (Irvine, US). The FDA issued a Cleared decision on May 6, 2014, 26 days after receiving the submission on April 10, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K140916 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 2014
Decision Date May 06, 2014
Days to Decision 26 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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