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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 K041811
Device Name ABBOTT AXSYM TROPONIN-I ADV
Applicant
ABBOTT LABORATORIES
DEPT. 9V6, BLDG. AP6C-3
100 ABBOTT PARK ROAD
ABBOTT PARK,  IL  60064 -6095
Applicant Contact MARGARET PROCHNIAK
Correspondent
ABBOTT LABORATORIES
DEPT. 9V6, BLDG. AP6C-3
100 ABBOTT PARK ROAD
ABBOTT PARK,  IL  60064 -6095
Correspondent Contact MARGARET PROCHNIAK
Regulation Number862.1215
Classification Product Code
MMI  
Subsequent Product Codes
JIT   JJX  
Date Received07/06/2004
Decision Date 09/10/2004
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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