FDA 510(k) Application Details - K012329

Device Classification Name	Bromcresol Green Dye-Binding, Albumin   More FDA Info for this Device
510(K) Number	K012329
Device Name	Bromcresol Green Dye-Binding, Albumin
Applicant	WIENER LABORATORIES S.A.I.C. 2944 RIOBAMBA ROSARIO 2000 AR Other 510(k) Applications for this Company
Contact	VIVIANA CETOLA Other 510(k) Applications for this Contact
Regulation Number	862.1035   More FDA Info for this Regulation Number
Classification Product Code	CIX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/23/2001
Decision Date	09/21/2001
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