FDA 510(k) Application Details - K080085

Device Classification Name	Drug Mixture Control Materials   More FDA Info for this Device
510(K) Number	K080085
Device Name	Drug Mixture Control Materials
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	862.3280   More FDA Info for this Regulation Number
Classification Product Code	DIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/11/2008
Decision Date	04/30/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review