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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 K983070
Device Name CK
Applicant
ABBOTT LABORATORIES
DEPT. 09VA LC-2
1920 HURD DRIVE
IRVING,  TX  75038
Applicant Contact LINDA MORRIS
Correspondent
ABBOTT LABORATORIES
DEPT. 09VA LC-2
1920 HURD DRIVE
IRVING,  TX  75038
Correspondent Contact LINDA MORRIS
Regulation Number862.1215
Classification Product Code
CGS  
Date Received09/02/1998
Decision Date 02/16/1999
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
Recalls CDRH Recalls
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