510(k) Report

Devices descending from K894651

3 later devices reach Coulter Positive Control Cells through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K984216Immuno-Trol Control CellsCoulter Corp.19992—
+2K141932Aquios CL Flow Cytometer, Aquios Tetra-1 Panel,Aquios Tetra-2+Panel, Aquios Immuno-Trol…Beckman Coulter, Inc.201506
+2K013842Immuno-Trol Low CellsBeckman Coulter, Inc.20011—