510(k) Report

Devices descending from K020831

18 later devices reach PT S Test Strips and Controls for the Coaguchek S System, Models 2032422 and… through their predicates, nearest generation first.

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