510(k) Report

Devices descending from K905396

24 later devices reach Hemastix Reagent Strips through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100024Teco Diagnostics Uti Detection StripsTeco Diagnostics20114—
+1K063295Acon Uti Urinary Tract Infection Test StripsACON Laboratories, Inc.20070—
+1K061559Acon Urinalysis Reagent StripsAcon Laboratories Co.200601
+1K031947Bayer Clinitek Status AnalyzerBayer Healthcare, LLC200316—
+2K231045Healgen URS Test StripsHealgen Scientific,, LLC20233—
+2K142391Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips (…ACON Laboratories, Inc.20143—
+2K101673Uritek TC-101 Urine Analyzer, Urine Reagent Strips 10, Models TC-101, Urs-10Teco Diagnostics20110—
+2K091216Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797Siemens Healthcare Diagnostics200964
+2K070929Acon U120 Urine Analyzer, Model U111-101ACON Laboratories, Inc.20073—
+3K251800Healgen® URS Test StripsHealgen Scientific,, LLC20250—
+3K252607AllTest Urinary Tract Infection TestHangzhou AllTest Biotech Co., Ltd.20250—
+3K242767Safecare Urinary Tract Infection TestSafecare Biotech (Hangzhou) Co., Ltd.20250—
+3K232317UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine…Urit Medical Electronic Co., Ltd.20240—
+3K182384ACR LAB Urine Analysis Test SystemHealthy.Io, Ltd.20191—
+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—
+3K142543Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube…ACON Laboratories, Inc.20150—
+3K111221Mission U500 Urine AnalyzerACON Laboratories, Inc.20121—
+4K252619Qscheck UisacrQstag, Inc.20260—
+4K210069Minuteful - kidney testHealthy.Io, Ltd.20221—
+4K173327DIP/U.S. Urine Analysis Test SystemHealthy.Io, Ltd.20180—
+5K222921Minuteful-kidney testHealthy.Io, Ltd.20230—