Cleared Traditional

CREATINE KINASE UV REAGENT SET

K905588 · Biochemical Trade, Inc. · Chemistry
Jan 1991
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K905588 is an FDA 510(k) clearance for the CREATINE KINASE UV REAGENT SET, a U.v. Method, Cpk Isoenzymes (Class II — Special Controls, product code JHW), submitted by Biochemical Trade, Inc. (Miami, US). The FDA issued a Cleared decision on January 17, 1991, 35 days after receiving the submission on December 13, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K905588 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 1990
Decision Date January 17, 1991
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JHW — U.v. Method, Cpk Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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