510(k) Report

Devices descending from K013380

4 later devices reach Acon Mop One Step Opiate Test Strip, Acon Mop Step Opiate Test Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080467Bionexa Single and Multi-Strip Cassette/Dipstick Doa Screen Panels ( Amp, Bar, Bzo, Coc…Applied Dna Technologies, Inc.20080—
+1K041743Acon Tri-Fect Drug Screen Test DeviceACON Laboratories, Inc.20040—
+1K041685Acon Multi-Clin Drug Screen Test DeviceACON Laboratories, Inc.20041—
+2K122752Fastect II PPX Drug Screen Dipstick, Fastect II Drug Screen Dipstick, Quicktox Drug…Branan Medical Corp.20130—