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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name fibrinogen and fibrin split products, antigen, antiserum, control
510(k) Number K110303
Device Name STRATUS CS ACUTE CARE D-DIMER
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
500 GBC DRIVE
MS 514
NEWARK,  DE  19702
Applicant Contact KATHLEEN ANN DRAY-LYONS
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
500 GBC DRIVE
MS 514
NEWARK,  DE  19702
Correspondent Contact KATHLEEN ANN DRAY-LYONS
Regulation Number864.7320
Classification Product Code
DAP  
Date Received02/01/2011
Decision Date 05/16/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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