FDA 510(k) Application Details - K132664

Device Classification Name	Bromcresol Purple Dye-Binding, Albumin   More FDA Info for this Device
510(K) Number	K132664
Device Name	Bromcresol Purple Dye-Binding, Albumin
Applicant	SIEMENS HEALTHCARE DIAGNOSTICS, INC. 511 BENEDICT AVE TARRYTOWN, NY 10591 US Other 510(k) Applications for this Company
Contact	KIRA GORDON 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	08/27/2013
Decision Date	10/16/2013
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