510(k) Report

Devices descending from K240124

2 later devices reach BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative…Healgen Scientific,, LLC20250—
+1K241869BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™…Vivachek Biotech (Hangzhou) Co., Ltd.20240—