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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 K013912
Device Name CREATINE KINASE (CK-NAC)
Applicant
JAS Diagnostics, Inc.
7220 NW 58TH ST.
MIAMI,  FL  33166
Applicant Contact David Johnston
Correspondent
JAS Diagnostics, Inc.
7220 NW 58TH ST.
MIAMI,  FL  33166
Correspondent Contact David Johnston
Regulation Number862.1215
Classification Product Code
CGS  
Date Received11/27/2001
Decision Date 01/18/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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