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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunoassay Method, Troponin Subunit
510(k) Number K060875
Device Name ABBOTT AXSYM TROPONIN-I ADV
Applicant
ABBOTT LABORATORIES
100 ABBOTT PARK ROAD
ABBOTT PARK,  IL  60064 -3500
Applicant Contact MARGARET PROCHNIAK
Correspondent
ABBOTT LABORATORIES
100 ABBOTT PARK ROAD
ABBOTT PARK,  IL  60064 -3500
Correspondent Contact MARGARET PROCHNIAK
Regulation Number862.1215
Classification Product Code
MMI  
Date Received03/30/2006
Decision Date 06/14/2006
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
Recalls CDRH Recalls
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