Cleared Traditional

CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC

K080973 · Cliniqa Corporation · Chemistry
Jun 2008
Decision
59d
Days
Class 1
Risk

About This 510(k) Submission

K080973 is an FDA 510(k) clearance for the CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Cliniqa Corporation (San Marcos, US). The FDA issued a Cleared decision on June 2, 2008, 59 days after receiving the submission on April 4, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K080973 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 2008
Decision Date June 02, 2008
Days to Decision 59 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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