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FDA 510(k) Application Details - K093626
Device Classification Name
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
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510(K) Number
K093626
Device Name
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
500 GBC DRIVE
MS 514
NEWARK, DE 19702 US
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Contact
KATHLEEN A DRAY-LYONS
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Regulation Number
864.7320
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Classification Product Code
DAP
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More FDA Info for this Product Code
Date Received
11/24/2009
Decision Date
11/29/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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