FDA 510(k) Application Details - K963306

Device Classification Name	Enzyme Immunoassay, Procainamide   More FDA Info for this Device
510(K) Number	K963306
Device Name	Enzyme Immunoassay, Procainamide
Applicant	BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. P.O. BOX 4117 CONCORD, CA 94524-4117 US Other 510(k) Applications for this Company
Contact	BESTY SOARES-MADDOX 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	08/22/1996
Decision Date	10/29/1996
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