FDA 510(k) Applications for Medical Device Product Code: OTF ()

FDA 510(k) Applications for Medical Device Product Code "OTF"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K101574	ARK DIAGNOSTICS,INC	ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0	11/23/2010