FDA 510(k) Application Details - K971445

Device Classification Name	Bromcresol Green Dye-Binding, Albumin   More FDA Info for this Device
510(K) Number	K971445
Device Name	Bromcresol Green Dye-Binding, Albumin
Applicant	CAROLINA LIQUID CHEMISTRIES CORP. 451 WEST LAMBERT RD., SUITE 207 BREA, CA 92821 US Other 510(k) Applications for this Company
Contact	CYNTHIA SHUGART 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	04/21/1997
Decision Date	05/02/1997
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