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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 K033487
Device Name STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI
Applicant
DADE BEHRING, INC.
P.O. BOX 6101 BUILDING 500
GLASGOW BUSINESS COMMUNITY
NEWARK,,  DE  19714
Applicant Contact GEORGE M PLUMMER
Correspondent
DADE BEHRING, INC.
P.O. BOX 6101 BUILDING 500
GLASGOW BUSINESS COMMUNITY
NEWARK,,  DE  19714
Correspondent Contact GEORGE M PLUMMER
Regulation Number862.1215
Classification Product Code
MMI  
Date Received11/04/2003
Decision Date 12/24/2003
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
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