510(k) Report

Devices descending from K071041

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220282i-STAT PTplus Cartridge with the i-STAT 1 SystemAbbott Laboratories20230—
+1K180684CoaguChek XS Plus SystemRoche Diagnostics20181Class I
+1K093460Coaguchek XS Pro SystemRoche Diagnostics20101Class I
+1K092940Coaguchek XS Plus PST SystemRoche Diagnostics Corp.20100—
+2K253188CoaguChek XS Plus SystemRoche Diagnostics20250—
+2K180693CoaguChek XS Pro SystemRoche Diagnostics20180—