FDA 510(k) Application Details - K070822

Device Classification Name	Sirolimus Test System   More FDA Info for this Device
510(K) Number	K070822
Device Name	Sirolimus Test System
Applicant	FUJIREBIO DIAGNOSTICS, INC. 201 GREAT VALLEY PARKWAY MALVERN, PA 19355-1308 US Other 510(k) Applications for this Company
Contact	DIANA LYN DICKSON 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	03/26/2007
Decision Date	09/28/2007
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