Cleared Traditional

LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK

K140764 · Bio-Rad Laboratories · Immunology
Apr 2014
Decision
29d
Days
Class 1
Risk

About This 510(k) Submission

K140764 is an FDA 510(k) clearance for the LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, 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 April 25, 2014, 29 days after receiving the submission on March 27, 2014. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K140764 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 2014
Decision Date April 25, 2014
Days to Decision 29 days
Submission Type Traditional
Review Panel Immunology (IM)
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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