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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nadh Oxidation/Nad Reduction, Ast/Sgot
510(k) Number K071525
Device Name ACTIVATED ASPARTATE AMINOTRANSFERASE
Applicant
ABBOTT LABORATORIES
1920 HURD DRIVE
IRVING,  TX  75038
Applicant Contact LINDA MORRIS
Correspondent
ABBOTT LABORATORIES
1920 HURD DRIVE
IRVING,  TX  75038
Correspondent Contact LINDA MORRIS
Regulation Number862.1100
Classification Product Code
CIT  
Date Received06/04/2007
Decision Date 03/19/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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