FDA 510(k) Application Details - K032334

Device Classification Name	Enzyme Immunoassay, Lidocaine   More FDA Info for this Device
510(K) Number	K032334
Device Name	Enzyme Immunoassay, Lidocaine
Applicant	ROCHE DIAGNOSTICS CORP. P.O. BOX 50457 9115 HAGUE RD. INDIANAPOLIS, IN 46250-0457 US Other 510(k) Applications for this Company
Contact	MIKE FLIS Other 510(k) Applications for this Contact
Regulation Number	862.3555   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	07/29/2003
Decision Date	01/12/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review