FDA 510(k) Application Details - K053131

Device Classification Name	Enzymatic Method, Bilirubin   More FDA Info for this Device
510(K) Number	K053131
Device Name	Enzymatic Method, Bilirubin
Applicant	WAKO CHEMICALS, USA, INC. 1600 BELLWOOD ROAD RICHMOND, VA 23237 US Other 510(k) Applications for this Company
Contact	LORI CREASY Other 510(k) Applications for this Contact
Regulation Number	862.1110   More FDA Info for this Regulation Number
Classification Product Code	JFM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/08/2005
Decision Date	12/30/2005
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