510(k) Report

Devices descending from K070009

5 later devices reach AT Home Drug Test Models, 9308T and 9308X through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181945QuickScreen Pro Multi Drug Screening Test, Model 9395ZPhamatech, Inc.20180—
+1K103295Quickscreen Cocaine 150 Screening TestPhamatech, Inc.20123—
+2K153192Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen…Chemtron Biotech, Inc.20162—
+3K232736Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen…Chemtron Biotech, Inc.20231—
+4K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc.20260—