FDA 510(k) Application Details - K040761

Device Classification Name	Cyclosporine   More FDA Info for this Device
510(K) Number	K040761
Device Name	Cyclosporine
Applicant	ABBOTT LABORATORIES INC 100 ABBOTT PARK ROAD ABBOTT PARK, IL 60064 US Other 510(k) Applications for this Company
Contact	GRACE LEMIEUX 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	03/25/2004
Decision Date	04/30/2004
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