510(k) Report

Devices descending from K030169

4 later devices reach Setpoint Chemistry Calibrator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031683Tox Ammonia CalibratorBayer Healthcare, LLC200301
+1K031682Lipoprotein CalibratorBayer Healthcare, LLC20032—
+2K051619Lipoprotein for Multiple AnalytesBayer Healthcare, LLC20051—
+3K061139Bayer Advia Ims Psa Calibrator and Advia Ims Cpsa CalibratorsBayer Healthcare, LLC20060—