FDA 510(k) Application Details - K963158

Device Classification Name	Enzyme Immunoassay, Digitoxin   More FDA Info for this Device
510(K) Number	K963158
Device Name	Enzyme Immunoassay, Digitoxin
Applicant	ABBOTT LABORATORIES DEPT. 389, AP30 200 ABBOTT PARK RD. ABBOTT PARK, IL 60064-3537 US Other 510(k) Applications for this Company
Contact	GRACE LEMIEUX Other 510(k) Applications for this Contact
Regulation Number	862.3300   More FDA Info for this Regulation Number
Classification Product Code	LFM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/26/1996
Decision Date	09/10/1996
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