510(k) Report

Devices descending from K153192

2 later devices reach Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232736Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen…Chemtron Biotech, Inc.20231—
+2K252684Labcorp Fentanyl Urine Visual TestMedtox Diagnostics, Inc.20260—