FDA 510(k) Application Details - K030428

Device Classification Name	Enzyme Immunoassay, Diphenylhydantoin   More FDA Info for this Device
510(K) Number	K030428
Device Name	Enzyme Immunoassay, Diphenylhydantoin
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. PO BX 50457 INDIANAPOLIS, IN 46250-0457 US Other 510(k) Applications for this Company
Contact	MIKE FLIS Other 510(k) Applications for this Contact
Regulation Number	862.3350   More FDA Info for this Regulation Number
Classification Product Code	DIP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/10/2003
Decision Date	04/28/2003
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