FDA 510(k) Application Details - K111904

Device Classification Name	Enzyme Immunoassay, Methotrexate   More FDA Info for this Device
510(K) Number	K111904
Device Name	Enzyme Immunoassay, Methotrexate
Applicant	ARK DIAGNOSTICS,INC 1190 BORDEAUX DRIVE SUNNYVALE, CA 94089 US Other 510(k) Applications for this Company
Contact	KENNETH C KASPER Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LAO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/05/2011
Decision Date	10/18/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review