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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
510(k) Number K060369
Device Name STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK
Applicant
DADE BEHRING, INC.
PO BOX 6101
NEWARK,  DE  19714 -6101
Applicant Contact KATHLEEN DRAY-LYON
Correspondent
DADE BEHRING, INC.
PO BOX 6101
NEWARK,  DE  19714 -6101
Correspondent Contact KATHLEEN DRAY-LYON
Regulation Number866.5270
Classification Product Code
NQD  
Subsequent Product Code
JIT  
Date Received02/13/2006
Decision Date 05/04/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
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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