Cleared Traditional

CREATINE KINASE (CK-NAC)

K013912 · Jas Diagnostics, Inc. · Chemistry
Jan 2002
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K013912 is an FDA 510(k) clearance for the CREATINE KINASE (CK-NAC), a Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (Class II — Special Controls, product code CGS), submitted by Jas Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on January 18, 2002, 52 days after receiving the submission on November 27, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K013912 FDA.gov
FDA Decision Cleared SESE
Date Received November 27, 2001
Decision Date January 18, 2002
Days to Decision 52 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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