510(k) Report

Devices descending from K060896

4 later devices reach Modification to Ontrak Testcup II and Onsite Cupkit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153192Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen…Chemtron Biotech, Inc.20162—
+1K143599Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000Chemtron Biotech, Inc.20150—
+2K232736Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen…Chemtron Biotech, Inc.20231—
+3K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc.20260—