510(k) Report

Devices descending from K965053

15 later devices reach Tritest Reagent CD3 Fitc/CD4 PE/CD45 Percp; Trucount Absolute Count Tubes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090810Thermo Scientific Cyto-Cal Count TubesMicrogenics Corp.20090—
+1K071141BD Tritest CD3/CD4/CD45 with BD Trucount Absolute Count Tubes, Model 340402Bd Biosciences20072—
+1K053497Guava EZCD4 SystemGuava Technologies, Inc.20060—
+1K974360Multitest CD3/CD8/CD45/CD4Becton Dickinson Immunocytometry Systems199810—
+2K170974BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD…Becton, Dickinson and Company2017117
+2K150815BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge KitBecton, Dickinson and Company201501
+2K141932Aquios CL Flow Cytometer, Aquios Tetra-1 Panel,Aquios Tetra-2+Panel, Aquios Immuno-Trol…Beckman Coulter, Inc.201506
+2K101911Immuknow-the Cylex Immune Cellfunction AssayCylex, Inc.20100—
+2K081213BD Facscount CD4 Reagents with Model 339010Bd Biosciences200802
+2K060423Cyan DXD, Multitest CD8/CD4/CD3, CD3-Fitc, CD3-Rpe, CD3-Apc and FluorospheresDakocytomation California, Inc.20060—
+2K013169Immune Cell Function AssayCylex, Inc.20020—
+2K980858Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing SolutionBecton Dickinson Immunocytometry Systems199851
+3K201814BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations)…Becton, Dickinson and Company202005
+3K060375BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models 337 and 166Bd Biosciences20063—
+4K090967BD Multitest 6-Color TBNK Reagent, Model 644611Bd Biosciences200923