Cleared Traditional

CREATINE PHOSPHOKINASE

K903775 · Amresco, Inc. · Chemistry
Oct 1990
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K903775 is an FDA 510(k) clearance for the CREATINE PHOSPHOKINASE, a Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (Class II — Special Controls, product code CGS), submitted by Amresco, Inc. (Solon, US). The FDA issued a Cleared decision on October 4, 1990, 45 days after receiving the submission on August 20, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K903775 FDA.gov
FDA Decision Cleared SESE
Date Received August 20, 1990
Decision Date October 04, 1990
Days to Decision 45 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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