Cleared Traditional

LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK

K122838 · Bio-Rad Laboratories · Chemistry
Oct 2012
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K122838 is an FDA 510(k) clearance for the LIQUICKEK IMMUNOASSAY PLUS CONTROL, LEVEL 1 MODEL 267, LIQUICHEK IMMUNOASSAY PLUS CONTROL, LEVEL 2 MODEL 268, LIQUICHEK, 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 October 17, 2012, 30 days after receiving the submission on September 17, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K122838 FDA.gov
FDA Decision Cleared SESE
Date Received September 17, 2012
Decision Date October 17, 2012
Days to Decision 30 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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