FDA 510(k) Application Details - K993925

Device Classification Name	Urease And Glutamic Dehydrogenase, Urea Nitrogen   More FDA Info for this Device
510(K) Number	K993925
Device Name	Urease And Glutamic Dehydrogenase, Urea Nitrogen
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	862.1770   More FDA Info for this Regulation Number
Classification Product Code	CDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/18/1999
Decision Date	04/03/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review