510(k) Report

Devices descending from K031682

2 later devices reach Lipoprotein Calibrator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051619Lipoprotein for Multiple AnalytesBayer Healthcare, LLC20051—
+2K061139Bayer Advia Ims Psa Calibrator and Advia Ims Cpsa CalibratorsBayer Healthcare, LLC20060—