FDA 510(k) Application Details - K060773

Device Classification Name	Enzyme Immunoassay, Procainamide   More FDA Info for this Device
510(K) Number	K060773
Device Name	Enzyme Immunoassay, Procainamide
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	862.3320   More FDA Info for this Regulation Number
Classification Product Code	LAR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/22/2006
Decision Date	08/23/2006
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