510(k) Report

Devices descending from K120771

7 later devices reach Unicel DXH 800 Coulter Cellular Analysis System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140911Unicel DXH 800 Coulter Cellular Analysis System/ Unicel DXH Slidemaker Stainer Coulter…Beckman Coulter, Inc.20146Class I
+2K230878QScout Lab; QScout RLDAd Astra Diagnostics, Inc.20230—
+2K193124Unicel DxH 800 Coulter Cellular Analysis SystemBeckman Coulter202011
+2K181475DxH 520 Hematology InstrumentBeckman Coulter20190—
+2K162414UniCel DxH SlideMaker Stainer Coulter Cellular Analysis SystemBeckman Coulter, Inc.20161—
+2K141932Aquios CL Flow Cytometer, Aquios Tetra-1 Panel,Aquios Tetra-2+Panel, Aquios Immuno-Trol…Beckman Coulter, Inc.201506
+3K240252UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II…Beckman Coulter, Inc.202402