FDA 510(k) Application Details - K973055

Device Classification Name	Calibrator, Surrogate   More FDA Info for this Device
510(K) Number	K973055
Device Name	Calibrator, Surrogate
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	862.1150   More FDA Info for this Regulation Number
Classification Product Code	JIW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/15/1997
Decision Date	09/25/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review