510(k) Report

Devices descending from K012595

2 later devices reach Acon MTD One Step Methadone Test Strip and Test Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092048One Step Eddp (Methadone Metabolite) Test StripBiosite Incorporated20100—
+1K052197First Sign Drug of Abuse Urine Screening TestW.H.P.M., Inc.20060—