FDA 510(k) Application Details - K090282

Device Classification Name	Enzyme Immunoassay, Lidocaine   More FDA Info for this Device
510(K) Number	K090282
Device Name	Enzyme Immunoassay, Lidocaine
Applicant	THERMO FISHER SCIENTIFIC INC. 7998 GEORGETOWN ROAD SUITE 1000 INDIANAPOLIS, IN 46268-9046 US Other 510(k) Applications for this Company
Contact	JACK ROGERS Other 510(k) Applications for this Contact
Regulation Number	862.3555   More FDA Info for this Regulation Number
Classification Product Code	KLR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/05/2009
Decision Date	05/29/2009
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