Cleared Traditional

EMDS CREATINE KINASE ITEM NIMBER 65411

K893691 · Diagnostic Systems · Chemistry
Aug 1989
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K893691 is an FDA 510(k) clearance for the EMDS CREATINE KINASE ITEM NIMBER 65411, a Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (Class II — Special Controls, product code CGS), submitted by Diagnostic Systems (Gibbstown, US). The FDA issued a Cleared decision on August 31, 1989, 107 days after receiving the submission on May 16, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K893691 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 1989
Decision Date August 31, 1989
Days to Decision 107 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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