FDA 510(k) Application Details - K081857

Device Classification Name	Sirolimus Test System   More FDA Info for this Device
510(K) Number	K081857
Device Name	Sirolimus Test System
Applicant	Siemens Healthcare Diagnostics Inc. PO BOX 6101 NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	GEORGE M PLUMMER 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	07/01/2008
Decision Date	10/30/2008
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