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FDA 510(k) Application Details - K993482
Device Classification Name
Test, Fibrinogen
More FDA Info for this Device
510(K) Number
K993482
Device Name
Test, Fibrinogen
Applicant
KAMIYA BIOMEDICAL CO.
910 INDUSTRY DR.
SEATTLE, WA 98188-3412 US
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Contact
COLIN GETTY
Other 510(k) Applications for this Contact
Regulation Number
864.7340
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Classification Product Code
GIS
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More FDA Info for this Product Code
Date Received
10/14/1999
Decision Date
12/06/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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