510(k) Report

Devices descending from K231698

11 later devices reach AllTest Fentanyl Rapid Test (Urine) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242428Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek®…Guangzhou Decheng Biotechnology Co., Ltd.20250—
+1K233417AllTest Fentanyl Urine Test CassetteHangzhou AllTest Biotech Co., Ltd.20239—
+2K242802CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test CassetteHangzhou Clongene Biotech Co., Ltd.20240—
+2K241969Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop®…Qingdao Hightop Biotech Co., Ltd.20241—
+2K241741SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test…Guangzhou Wondfo Biotech Co., Ltd.20240—
+2K240949Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl…Healgen Scientific,, LLC20240—
+2K240654SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test CassetteSafecare Biotech (Hangzhou) Co., Ltd.20240—
+2K240295InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine)Instanosis, Inc.20240—
+2K234006AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl TestAllsource Screening Solutions20240—
+2K240351FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)Assure Tech., LLC20240—
+3K243064ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl…Eterbio, Inc.20240—