FDA 510(k) Application Details - K023105

Device Classification Name	Cresolphthalein Complexone, Calcium   More FDA Info for this Device
510(K) Number	K023105
Device Name	Cresolphthalein Complexone, Calcium
Applicant	ELAN DIAGNOSTICS 1075 W. LAMBERT RD., SUITE D BREA, CA 92821 US Other 510(k) Applications for this Company
Contact	WYNN STOCKING 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	09/18/2002
Decision Date	03/13/2003
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