510(k) Report

Devices descending from K791141

1 later device reach Bilirubin Calibrator Control through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053090Dri-Stat Enzymatic Bilirubin Reagent, Synchron Systems Bilirubin CalibratorBeckman Coulter, Inc.20050—