Cleared Traditional

CREATINE KINASE LIQUID REAGENT, MODEL C519-440

K072548 · Teco Diagnostics · Chemistry
Apr 2008
Decision
221d
Days
Class 2
Risk

About This 510(k) Submission

K072548 is an FDA 510(k) clearance for the CREATINE KINASE LIQUID REAGENT, MODEL C519-440, a Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (Class II — Special Controls, product code CGS), submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on April 18, 2008, 221 days after receiving the submission on September 10, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K072548 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 2007
Decision Date April 18, 2008
Days to Decision 221 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CGS — Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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