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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 K063756
Device Name DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE
Applicant
DADE BEHRING, INC.
BLDG. 500 MAIL BOX 514
P.O. BOX 6101
NEWARK,  DE  19714 -6101
Applicant Contact GEORGE M PLUMMER
Correspondent
DADE BEHRING, INC.
BLDG. 500 MAIL BOX 514
P.O. BOX 6101
NEWARK,  DE  19714 -6101
Correspondent Contact GEORGE M PLUMMER
Regulation Number862.1215
Classification Product Code
MMI  
Date Received12/19/2006
Decision Date 03/19/2007
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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