510(k) Report

Devices descending from K081822

3 later devices reach Coulter 6C Cell Control, Models 628027 & A59925 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181599Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator ApplicationBeckman Coulter20192—
+2K193124Unicel DxH 800 Coulter Cellular Analysis SystemBeckman Coulter202011
+3K240252UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II…Beckman Coulter, Inc.202402