FDA 510(k) Application Details - K101088

Device Classification Name	Bromcresol Green Dye-Binding, Albumin   More FDA Info for this Device
510(K) Number	K101088
Device Name	Bromcresol Green Dye-Binding, Albumin
Applicant	MEDICA CORP. 5 OAK PARK DRIVE BEDFORD, MA 01730 US Other 510(k) Applications for this Company
Contact	Photios Makris 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	04/19/2010
Decision Date	04/04/2011
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