Cleared Traditional

LIQUICHEK TUMOR MARKER CONTROL

K141073 · Bio-Rad Laboratories · Immunology
Jun 2014
Decision
59d
Days
Class 1
Risk

About This 510(k) Submission

K141073 is an FDA 510(k) clearance for the LIQUICHEK TUMOR MARKER CONTROL, 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 June 23, 2014, 59 days after receiving the submission on April 25, 2014. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K141073 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 2014
Decision Date June 23, 2014
Days to Decision 59 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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