FDA 510(k) Application Details - K012422

Device Classification Name	Control, Plasma, Abnormal   More FDA Info for this Device
510(K) Number	K012422
Device Name	Control, Plasma, Abnormal
Applicant	KAMIYA BIOMEDICAL CO. 910 INDUSTRY DR. SEATTLE, WA 98188-3412 US Other 510(k) Applications for this Company
Contact	DON TRAN Other 510(k) Applications for this Contact
Regulation Number	864.5425   More FDA Info for this Regulation Number
Classification Product Code	GGC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/30/2001
Decision Date	08/21/2001
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