FDA 510(k) Application Details - K000375

Device Classification Name	Cresolphthalein Complexone, Calcium   More FDA Info for this Device
510(K) Number	K000375
Device Name	Cresolphthalein Complexone, Calcium
Applicant	RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD CRUMLIN, CO. ANTRIM BT29 4QY GB Other 510(k) Applications for this Company
Contact	P. ARMSTRONG Other 510(k) Applications for this Contact
Regulation Number	862.1145   More FDA Info for this Regulation Number
Classification Product Code	CIC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/07/2000
Decision Date	04/05/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review