FDA 510(k) Application Details - K023058

Device Classification Name	Enzyme Immunoassay, Digoxin   More FDA Info for this Device
510(K) Number	K023058
Device Name	Enzyme Immunoassay, Digoxin
Applicant	SERADYN 7998 GEORGETOWN RD. SUITE 1000 INDIANAPOLIS, IN 46268 US Other 510(k) Applications for this Company
Contact	LISA BROWN 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	09/13/2002
Decision Date	10/24/2002
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