510(k) Report

Devices descending from K181599

2 later devices reach Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193124Unicel DxH 800 Coulter Cellular Analysis SystemBeckman Coulter202011
+2K240252UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II…Beckman Coulter, Inc.202402