FDA 510(k) Application Details - K032291

Device Classification Name	Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.   More FDA Info for this Device
510(K) Number	K032291
Device Name	Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.
Applicant	LINDE MEDICAL SENSORS AG AUSTRASSE 25 BASEL CH-4051 CH Other 510(k) Applications for this Company
Contact	JEAN-PIERRE PALMA Other 510(k) Applications for this Contact
Regulation Number	862.3320   More FDA Info for this Regulation Number
Classification Product Code	DOA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/24/2003
Decision Date	08/24/2004
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