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 Other 510(k) Applications for this Company
Contact	COLIN GETTY Other 510(k) Applications for this Contact
Regulation Number	864.7340   More FDA Info for this Regulation Number
Classification Product Code	GIS Other 510(k) Applications for this Device   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