510(k) Report

Devices descending from K023840

6 later devices reach Acid Phosphatase Assay for the Advia 1650 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030804Bayer Advia 1650 Special Chemistry CalibratorBayer Healthcare, LLC20031—
+1K030801Bayer Advia 1650 Special Chemistry ControlBayer Healthcare, LLC20033—
+2K033379Bayer Special Chemistry ControlsBayer Diagnostics Corp.20031—
+2K033380Bayer Special Chemistry CalibratorsBayer Diagnostics Corp.20030—
+2K031644Bayer Advia Chemistry Special Chemistry ControlBayer Healthcare, LLC20030—
+3K061137Advia Ims Cpsa ControlBayer Healthcare, LLC20060—