510(k) Report

Devices descending from K991080

3 later devices reach Accusign MTD, Biosign MTD through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K012595Acon MTD One Step Methadone Test Strip and Test DeviceACON Laboratories, Inc.20012—
+2K092048One Step Eddp (Methadone Metabolite) Test StripBiosite Incorporated20100—
+2K052197First Sign Drug of Abuse Urine Screening TestW.H.P.M., Inc.20060—