510(k) Report

Devices descending from K053533

2 later devices reach Immulite/Immulite 1000 Turbo Intact PTH through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061190Access Intact PTH and Calibrators, Models a 16972 and a 16953Beckman Coulter, Inc.200611
+2K232791Access Intact PTHBeckman Coulter, Inc.202401