510(k) Report

Devices descending from K020801

13 later devices reach Quickvue One-Step HCG-Combo through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132834Fastep S10 HCG Serum/Urine Combo TestPolymed Therapeutics, Inc.20143—
+1K032563Clinitest HCG Pregnancy TestBayer Healthcare, LLC200372
+1K023544Genzyme Contrast II HCG Urine/Serum TestGenzyme Corp.20030—
+2K203272Alltest Pregnancy Rapid Combo Test CassetteHangzhou AllTest Biotech Co., Ltd.20222—
+2K091216Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797Siemens Healthcare Diagnostics200964
+3K262299Instant-View® hCG Combo II Cassette TestAlfa Scientific Designs, Inc.20260—
+3K241919Innovita HCG Pregnancy Rapid Combo TestInnovita (Tangshan) Biological Technology Co., Ltd.20240—
+3K171521DUS R-50S (Urine Chemistry system)DFI Co., Ltd.20180—
+3K160372Uritek TC-201 Urine Chemistry Test SystemTeco Diagnostics, Inc.20160—
+3K152835Uritek TC-201 Urine Chemistry Test SystemTeco Diagnostics, Inc.20160—
+3K141874Uriscan OptimaYd Diagnostics Corp.20152—
+4K210069Minuteful - kidney testHealthy.Io, Ltd.20221—
+5K222921Minuteful-kidney testHealthy.Io, Ltd.20230—