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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 K053020
Device Name TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM
Applicant
BAYER HEALTHCARE, LLC
511 BENEDICT AVE.
TARRYTOWN,  NY  10591
Applicant Contact ANDRES HOLLE
Correspondent
BAYER HEALTHCARE, LLC
511 BENEDICT AVE.
TARRYTOWN,  NY  10591
Correspondent Contact ANDRES HOLLE
Regulation Number862.1215
Classification Product Code
MMI  
Subsequent Product Code
JIT  
Date Received10/26/2005
Decision Date 12/30/2005
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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