FDA 510(k) Application Details - K980521

Device Classification Name	Enzyme Immunoassay, Digoxin   More FDA Info for this Device
510(K) Number	K980521
Device Name	Enzyme Immunoassay, Digoxin
Applicant	BAYER CORP. 511 BENEDICT AVE. TARRYTOWN, NY 10591-5097 US Other 510(k) Applications for this Company
Contact	GABRIEL J MURACA, JR. 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	01/28/1998
Decision Date	04/02/1998
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