FDA 510(k) Application Details - K093441

Device Classification Name	Enzyme Immunoassay, Digoxin   More FDA Info for this Device
510(K) Number	K093441
Device Name	Enzyme Immunoassay, Digoxin
Applicant	SIEMENS HEALTHCARE DIAGNOSTICS MS 514, PO BOX 6101 NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	FRANCES A DILLON 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	11/05/2009
Decision Date	04/07/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review