Cleared Traditional

LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK

K130963 · Bio-Rad Laboratories, Inc. · Chemistry
May 2013
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K130963 is an FDA 510(k) clearance for the LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Bio-Rad Laboratories, Inc. (Irvine, US). The FDA issued a Cleared decision on May 6, 2013, 28 days after receiving the submission on April 8, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K130963 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 2013
Decision Date May 06, 2013
Days to Decision 28 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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