510(k) Report

Devices descending from K233417

9 later devices reach AllTest Fentanyl Urine Test Cassette through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242802CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test CassetteHangzhou Clongene Biotech Co., Ltd.20240—
+1K241969Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop®…Qingdao Hightop Biotech Co., Ltd.20241—
+1K241741SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test…Guangzhou Wondfo Biotech Co., Ltd.20240—
+1K240949Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl…Healgen Scientific,, LLC20240—
+1K240654SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test CassetteSafecare Biotech (Hangzhou) Co., Ltd.20240—
+1K240295InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine)Instanosis, Inc.20240—
+1K234006AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl TestAllsource Screening Solutions20240—
+1K240351FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)Assure Tech., LLC20240—
+2K243064ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl…Eterbio, Inc.20240—