FDA 510(k) Application Details - K101305

Device Classification Name	Lamotrigine Assay   More FDA Info for this Device
510(K) Number	K101305
Device Name	Lamotrigine Assay
Applicant	ARK DIAGNOSTICS,INC 1190 BORDEAUX DRIVE SUNNYVALE, CA 94089 US Other 510(k) Applications for this Company
Contact	JOHNNY VALDEZ Other 510(k) Applications for this Contact
Regulation Number	862.3350   More FDA Info for this Regulation Number
Classification Product Code	ORH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/10/2010
Decision Date	10/29/2010
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