510(k) Report

Devices descending from K030801

3 later devices reach Bayer Advia 1650 Special Chemistry Control through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033379Bayer Special Chemistry ControlsBayer Diagnostics Corp.20031—
+1K031644Bayer Advia Chemistry Special Chemistry ControlBayer Healthcare, LLC20030—
+2K061137Advia Ims Cpsa ControlBayer Healthcare, LLC20060—