FDA 510(k) Application Details - K052017

Device Classification Name	Cyclosporine   More FDA Info for this Device
510(K) Number	K052017
Device Name	Cyclosporine
Applicant	DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY; BLDG. 500 MAIL BOX 514 P.O. BOX 6101, NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	ANDREA M TASKER Other 510(k) Applications for this Contact
Regulation Number	862.1235   More FDA Info for this Regulation Number
Classification Product Code	MKW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/26/2005
Decision Date	09/01/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review