FDA 510(k) Application Details - K993928

Device Classification Name	Igg, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K993928
Device Name	Igg, Antigen, Antiserum, Control
Applicant	WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD RICHMOND, VA 23237 US Other 510(k) Applications for this Company
Contact	TANYA MALLORY Other 510(k) Applications for this Contact
Regulation Number	866.5510   More FDA Info for this Regulation Number
Classification Product Code	DEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/18/1999
Decision Date	01/18/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review