Cleared Traditional

CREATINE KINASE TEST

K931889 · Em Diagnostic Systems, Inc. · Chemistry
Jul 1993
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K931889 is an FDA 510(k) clearance for the CREATINE KINASE TEST, a Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (Class II — Special Controls, product code CGS), submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on July 27, 1993, 103 days after receiving the submission on April 15, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K931889 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 1993
Decision Date July 27, 1993
Days to Decision 103 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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