FDA 510(k) Application Details - K071644

Device Classification Name	Enzyme Immunoassay, Phenobarbital   More FDA Info for this Device
510(K) Number	K071644
Device Name	Enzyme Immunoassay, Phenobarbital
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	DIMITRIS DEMIRTZOGLOU Other 510(k) Applications for this Contact
Regulation Number	862.3660   More FDA Info for this Regulation Number
Classification Product Code	DLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/15/2007
Decision Date	09/12/2007
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