FDA 510(k) Application Details - K101574

Device Classification Name	More FDA Info for this Device
510(K) Number	K101574
Device Name	ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0
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	More FDA Info for this Regulation Number
Classification Product Code	OTF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/07/2010
Decision Date	11/23/2010
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