FDA 510(k) Application Details - K024280

Device Classification Name	C-Reactive Protein, Antigen, Antiserum, And Control   More FDA Info for this Device
510(K) Number	K024280
Device Name	C-Reactive Protein, Antigen, Antiserum, And Control
Applicant	WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD RICHMOND, VA 23237 US Other 510(k) Applications for this Company
Contact	TONYA MALLORY Other 510(k) Applications for this Contact
Regulation Number	866.5270   More FDA Info for this Regulation Number
Classification Product Code	DCK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2002
Decision Date	06/06/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review