FDA 510(k) Application Details - K042411

Device Classification Name	Sirolimus Test System   More FDA Info for this Device
510(K) Number	K042411
Device Name	Sirolimus Test System
Applicant	AXIS-SHIELD LTD. THE TECHNOLOGY PARK DUNDEE, TAYSIDE, SCOTLAND DD21XA GB Other 510(k) Applications for this Company
Contact	SUSAN LEONARD Other 510(k) Applications for this Contact
Regulation Number	862.3840   More FDA Info for this Regulation Number
Classification Product Code	NRP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/07/2004
Decision Date	04/07/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review