FDA 510(k) Application Details - K061249

Device Classification Name	Enzyme Immunoassay, Digoxin   More FDA Info for this Device
510(K) Number	K061249
Device Name	Enzyme Immunoassay, Digoxin
Applicant	ABBOTT LABORATORIES D 9VA, BLDG. AP6C-2 100 ABBOTT PARK RD ABBOTT PARK, IL 60064-3500 US Other 510(k) Applications for this Company
Contact	KENTON SMITH Other 510(k) Applications for this Contact
Regulation Number	862.3320   More FDA Info for this Regulation Number
Classification Product Code	KXT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/04/2006
Decision Date	06/02/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review