510(k) Report

Devices descending from K140911

6 later devices reach Unicel DXH 800 Coulter Cellular Analysis System/ Unicel DXH Slidemaker Stainer… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230878QScout Lab; QScout RLDAd Astra Diagnostics, Inc.20230—
+1K193124Unicel DxH 800 Coulter Cellular Analysis SystemBeckman Coulter202011
+1K181475DxH 520 Hematology InstrumentBeckman Coulter20190—
+1K162414UniCel DxH SlideMaker Stainer Coulter Cellular Analysis SystemBeckman Coulter, Inc.20161—
+1K141932Aquios CL Flow Cytometer, Aquios Tetra-1 Panel,Aquios Tetra-2+Panel, Aquios Immuno-Trol…Beckman Coulter, Inc.201506
+2K240252UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II…Beckman Coulter, Inc.202402