FDA 510(k) Application Details - K000483

Device Classification Name	Bromcresol Purple Dye-Binding, Albumin   More FDA Info for this Device
510(K) Number	K000483
Device Name	Bromcresol Purple Dye-Binding, Albumin
Applicant	RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, CO. ANTRIM BT29 4QY IE Other 510(k) Applications for this Company
Contact	P ARMSTRONG Other 510(k) Applications for this Contact
Regulation Number	862.1035   More FDA Info for this Regulation Number
Classification Product Code	CJW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/14/2000
Decision Date	03/31/2000
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