FDA 510(k) Application Details - K000361

Device Classification Name	Antithrombin Iii Quantitation   More FDA Info for this Device
510(K) Number	K000361
Device Name	Antithrombin Iii Quantitation
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	864.7060   More FDA Info for this Regulation Number
Classification Product Code	JBQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/04/2000
Decision Date	04/26/2000
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