Cleared Traditional

RAICHEM(TM) CREATINE KINASE-MB REAGENT

K913398 · Reagents Applications, Inc. · Chemistry
Sep 1991
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K913398 is an FDA 510(k) clearance for the RAICHEM(TM) CREATINE KINASE-MB REAGENT, a Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (Class II — Special Controls, product code CGS), submitted by Reagents Applications, Inc. (San Diego, US). The FDA issued a Cleared decision on September 25, 1991, 57 days after receiving the submission on July 30, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K913398 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 1991
Decision Date September 25, 1991
Days to Decision 57 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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