Cleared Traditional

LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648

K012656 · Bio-Rad · Chemistry
Sep 2001
Decision
24d
Days
Class 1
Risk

About This 510(k) Submission

K012656 is an FDA 510(k) clearance for the LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648, a Enzyme Controls (assayed And Unassayed) (Class I — General Controls, product code JJT), submitted by Bio-Rad (Irvine, US). The FDA issued a Cleared decision on September 6, 2001, 24 days after receiving the submission on August 13, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K012656 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 2001
Decision Date September 06, 2001
Days to Decision 24 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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