510(k) Report

Devices descending from K091216

6 later devices reach Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171521DUS R-50S (Urine Chemistry system)DFI Co., Ltd.20180—
+1K160372Uritek TC-201 Urine Chemistry Test SystemTeco Diagnostics, Inc.20160—
+1K152835Uritek TC-201 Urine Chemistry Test SystemTeco Diagnostics, Inc.20160—
+1K141874Uriscan OptimaYd Diagnostics Corp.20152—
+2K210069Minuteful - kidney testHealthy.Io, Ltd.20221—
+3K222921Minuteful-kidney testHealthy.Io, Ltd.20230—