510(k) Report

Devices descending from K010599

20 later devices reach Protime Microcoagulation System / Protime 3 Cuvette through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K021190PT-S Test Strips for the Coaguchek System, Model# 2032422Roche Diagnostics Corp.200201
+1K020831PT S Test Strips and Controls for the Coaguchek S System, Models 2032422 and 3271404Roche Diagnostics Corp.200218—
+2K071265Smartcheck Inr SystemInverness Medical Innovations, Inc.20070—
+2K060978Coaguchek XS SystemRoche Diagnostics2006163
+3K230802Xprecia Prime Coagulation SystemUniversal Biosensors Pty, Ltd.20240—
+3K180780microINR SystemIline Microsystems, S.L.20194—
+3K151964Xprecia Stride Coagulation System, Xprecia System PT ControlsSiemens Healthcare Diagnostics20160—
+3K071041Coaguchek XS Plus SystemRoche Diagnostics20076Class I
+3K062925Coaguchek XS SystemRoche Diagnostics Corp.200714
+4K251564microINR SystemIline Microsystems, S.L.20250—
+4K243543microINR SystemIline Microsystems, S.L.20251—
+4K220282i-STAT PTplus Cartridge with the i-STAT 1 SystemAbbott Laboratories20230—
+4K201185microINR SystemIline Microsystems, S.L.20203—
+4K180684CoaguChek XS Plus SystemRoche Diagnostics20181Class I
+4K170960CoaguChek Vantus SystemRoche Diagnostics20170Class I
+4K093460Coaguchek XS Pro SystemRoche Diagnostics20101Class I
+4K092940Coaguchek XS Plus PST SystemRoche Diagnostics Corp.20100—
+5K253188CoaguChek XS Plus SystemRoche Diagnostics20250—
+5K231711microINR SystemIline Microsystems, S.L.20232—
+5K180693CoaguChek XS Pro SystemRoche Diagnostics20180—