Cleared Traditional

CK-NAC REAGENT

K852000 · Alpkem Corp. · Chemistry
May 1985
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K852000 is an FDA 510(k) clearance for the CK-NAC REAGENT, a Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (Class II — Special Controls, product code CGS), submitted by Alpkem Corp. (Clackamas, US). The FDA issued a Cleared decision on May 30, 1985, 23 days after receiving the submission on May 7, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K852000 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 1985
Decision Date May 30, 1985
Days to Decision 23 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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