510(k) Report

Devices descending from K912133

6 later devices reach PX Coulter (R) Cell Control through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082162Coulter Body Fluid ControlBeckman Coulter, Inc.20090—
+1K081822Coulter 6C Cell Control, Models 628027 & A59925Beckman Coulter, Inc.20093—
+1K060464Coulter 5C Cell ControlBeckman Coulter, Inc.20065—
+2K181599Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator ApplicationBeckman Coulter20192—
+3K193124Unicel DxH 800 Coulter Cellular Analysis SystemBeckman Coulter202011
+4K240252UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II…Beckman Coulter, Inc.202402