510(k) Report

Devices descending from K992399

2 later devices reach Additional Ims Assays for the Bayer Advia Ims System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063845Advia Chemistry Total Bilirubin_2Bayer Healthcare, LLC20071—
+2K152344Total BilirubinRandox Laboratories Limited201601