FDA 510(k) Application Details - K955444

Device Classification Name	Enzyme Immunoassay, Procainamide   More FDA Info for this Device
510(K) Number	K955444
Device Name	Enzyme Immunoassay, Procainamide
Applicant	ABBOTT LABORATORIES DEPT: 09V8 BLDG: AP5-2 100 ABBOTT PARK ROAD ABBOTT PARK, IL 60064-3500 US Other 510(k) Applications for this Company
Contact	GRACE LEMIEUX 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	11/28/1995
Decision Date	04/02/1996
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