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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 K093626
Device Name INNOVANCE D-DIMER, MODEL OPBP09
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
500 GBC DRIVE
MS 514
NEWARK,  DE  19702
Applicant Contact KATHLEEN A DRAY-LYONS
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
500 GBC DRIVE
MS 514
NEWARK,  DE  19702
Correspondent Contact KATHLEEN A DRAY-LYONS
Regulation Number864.7320
Classification Product Code
DAP  
Date Received11/24/2009
Decision Date 11/29/2010
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
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