FDA 510(k) Application Details - K091617

Device Classification Name	Calibrators, Drug Specific   More FDA Info for this Device
510(K) Number	K091617
Device Name	Calibrators, Drug Specific
Applicant	Thermo Fisher Scientific 7998 GEORGETOWN ROAD SUITE 1000 INDIANAPOLIS, IN 46268 US Other 510(k) Applications for this Company
Contact	JACK ROGERS Other 510(k) Applications for this Contact
Regulation Number	862.3200   More FDA Info for this Regulation Number
Classification Product Code	DLJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/03/2009
Decision Date	07/17/2009
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