FDA 510(k) Application Details - K081083

Device Classification Name	Mycophenolic Acid Test System   More FDA Info for this Device
510(K) Number	K081083
Device Name	Mycophenolic Acid Test System
Applicant	Thermo Fisher Scientific 46360 FREMONT BLVD. FREMONT, CA 94538 US Other 510(k) Applications for this Company
Contact	JACK ROGERS Other 510(k) Applications for this Contact
Regulation Number	862.3840   More FDA Info for this Regulation Number
Classification Product Code	OAV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/16/2008
Decision Date	12/19/2008
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