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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
510(k) Number K893691
Device Name EMDS CREATINE KINASE ITEM NIMBER 65411
Applicant
Diagnostic Systems
480 Democrat Rd.
Gibbstown,  NJ  08027
Applicant Contact ANNA BENTLEY
Correspondent
Diagnostic Systems
480 Democrat Rd.
Gibbstown,  NJ  08027
Correspondent Contact ANNA BENTLEY
Regulation Number862.1215
Classification Product Code
CGS  
Date Received05/16/1989
Decision Date 08/31/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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