FDA 510(k) Application Details - K993332

Device Classification Name	Control, Plasma, Abnormal   More FDA Info for this Device
510(K) Number	K993332
Device Name	Control, Plasma, Abnormal
Applicant	GRADIPORE LTD. LOT16 RIVERSIDE CORPORATE PARK 35-105 DELHI ROAD NORTH RYDE NSW 2113 AU Other 510(k) Applications for this Company
Contact	RHONDA PILGRIM 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	10/04/1999
Decision Date	02/16/2000
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