Cleared Traditional

K952745 - CREATINE KINASE REAGENT SYSTEM
(FDA 510(k) Clearance)

K952745 · Medical Diagnostic Technologies, Inc. · Chemistry
Aug 1995
Decision
56d
Days
Class 2
Risk

K952745 is an FDA 510(k) clearance for the CREATINE KINASE REAGENT SYSTEM, a Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (Class II — Special Controls, product code CGS), submitted by Medical Diagnostic Technologies, Inc. (Ventura, US). The FDA issued a Cleared decision on August 11, 1995, 56 days after receiving the submission on June 16, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K952745 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 1995
Decision Date August 11, 1995
Days to Decision 56 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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