510(k) Report

Devices descending from K241969

1 later device reach Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop®… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243064ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl…Eterbio, Inc.20240—