FDA 510(k) Application Details - K053401

Device Classification Name	Cresolphthalein Complexone, Calcium   More FDA Info for this Device
510(K) Number	K053401
Device Name	Cresolphthalein Complexone, Calcium
Applicant	ARKRAY, INC. 510 FURNACE DOCK RD. CORTLANDT MANOR, NY 10567 US Other 510(k) Applications for this Company
Contact	HELEN LANDICHO Other 510(k) Applications for this Contact
Regulation Number	862.1145   More FDA Info for this Regulation Number
Classification Product Code	CIC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/06/2005
Decision Date	03/24/2006
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