510(k) Report

Devices descending from K922744

18 later devices reach Cyto-Stat/Coulter Clone CD 3(IGG1)-Fitc/T8-RD1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K963263Tetraone System for Epics XL Flow Cytometry Systems and Cyto-Stat Tertrachrome…Coulter Corp.199715Class I
+1K962305Cyto-Stat Trichrome CD45-Fitc/CD8-RD1/CD3-PC5 Monoclonal Antibody Reagent Iwth Isotypic…Coulter Corp.19970—
+1K961278Coulter STKS Analyzer with CD4 & CD8 Lymphocyte AnalysisCoulter Corp.19960—
+2K990172Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome…Coulter Corp.199914Class I
+3K081526Flowcare TLG ReagentBeckman Coulter, Inc.20080—
+3K043215Flowcare PLG CD4 ReagentBeckman Coulter, Inc.20051—
+3K041882Flowcare SystemPointcare Technologies, Inc.20041—
+3K030828Tetracxp System (Software and System Guide)Beckman Coulter, Inc.20036Class I
+3K030408Cyto-Stat Tetrachrome CD45-Fit/CD4-PE/CD3-PC5 Monoclonal Antibody Reagent, Cyto-Stat…Beckman Coulter, Inc.200324
+4K182886Cytomics FC 500 Series (MPL or MCL) Flow CytometerBeckman Coulter20190—
+4K130373Navios Flow Cytometer SystemBeckman Coulter, Inc.20133—
+4K121445Tetrachrome Reagents and Tetracxp SystemBeckman Coulter, Inc.20130—
+4K082091Tri T-Stat Reagent Assay (Dried Form) Model 25107-00Reametrix, Inc.20090—
+4K072869Pointcare Now SystemPointcare Technologies, Inc.200801
+4K071681Cytomics FC 500 MPL Flow Cytometer, Model # 626554Beckman Coulter, Inc.20071Class I
+5K183592ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow CytometerBeckman Coulter20191—
+5K162897Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser…Beckman Coulter20172—
+6K232600DxFLEX Flow Cytometer; ClearLLab 10C PanelsBeckman Coulter, Inc.202301