510(k) Report

Devices descending from K060978

16 later devices reach Coaguchek XS System through their predicates, nearest generation first.

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