Cleared Traditional

LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL

K021498 · Bio-Rad · Chemistry
May 2002
Decision
15d
Days
Class 1
Risk

About This 510(k) Submission

K021498 is an FDA 510(k) clearance for the LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL, a Enzyme Controls (assayed And Unassayed) (Class I — General Controls, product code JJT), submitted by Bio-Rad (Ivrvine, US). The FDA issued a Cleared decision on May 24, 2002, 15 days after receiving the submission on May 9, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K021498 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 2002
Decision Date May 24, 2002
Days to Decision 15 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJT — Enzyme Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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