510(k) Report

Devices descending from K002738

3 later devices reach Bayer Rapidpoint 400 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151978EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN…Edan Instruments, Inc.20160—
+1K031560Bayer Rapidlab 1200 SystemBayer Healthcare, LLC2003114
+2K113216Rapidpoint 500 Blood Gas AnalyerSiemens Healthcare Diagnostics2012012