510(k) Report

Devices descending from K843174

1 later device reach Dri-Stat Enzymatic Bilirubin Test Kit through their predicates, nearest generation first.

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