Cleared Traditional

KING DIAGNOSTICS CK REAGENT

K931326 · King Diagnostics, Inc. · Chemistry
Jun 1993
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K931326 is an FDA 510(k) clearance for the KING DIAGNOSTICS CK REAGENT, a Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (Class II — Special Controls, product code CGS), submitted by King Diagnostics, Inc. (Indianapolis, US). The FDA issued a Cleared decision on June 15, 1993, 91 days after receiving the submission on March 16, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K931326 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 1993
Decision Date June 15, 1993
Days to Decision 91 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

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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