FDA 510(k) Application Details - K011302

Device Classification Name	Enzyme Immunoassay, Digoxin   More FDA Info for this Device
510(K) Number	K011302
Device Name	Enzyme Immunoassay, Digoxin
Applicant	RANDOX LABORATORIES, LTD. 55 DIAMOND RD. CRUMLIN, CO. ANTRIM BT29 4QY IE Other 510(k) Applications for this Company
Contact	PAULINE ARMSTRONG 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	04/30/2001
Decision Date	07/02/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review