Cleared Traditional

LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIAC MARKERS PLUS

K050537 · Bio-Rad · Chemistry
Apr 2005
Decision
56d
Days
Class 1
Risk

About This 510(k) Submission

K050537 is an FDA 510(k) clearance for the LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIAC MARKERS PLUS, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Bio-Rad (Irvine, US). The FDA issued a Cleared decision on April 27, 2005, 56 days after receiving the submission on March 2, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K050537 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 2005
Decision Date April 27, 2005
Days to Decision 56 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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