510(k) Report

Devices descending from K990172

14 later devices reach Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081526Flowcare TLG ReagentBeckman Coulter, Inc.20080—
+1K043215Flowcare PLG CD4 ReagentBeckman Coulter, Inc.20051—
+1K041882Flowcare SystemPointcare Technologies, Inc.20041—
+1K030828Tetracxp System (Software and System Guide)Beckman Coulter, Inc.20036Class I
+1K030408Cyto-Stat Tetrachrome CD45-Fit/CD4-PE/CD3-PC5 Monoclonal Antibody Reagent, Cyto-Stat…Beckman Coulter, Inc.200324
+2K182886Cytomics FC 500 Series (MPL or MCL) Flow CytometerBeckman Coulter20190—
+2K130373Navios Flow Cytometer SystemBeckman Coulter, Inc.20133—
+2K121445Tetrachrome Reagents and Tetracxp SystemBeckman Coulter, Inc.20130—
+2K082091Tri T-Stat Reagent Assay (Dried Form) Model 25107-00Reametrix, Inc.20090—
+2K072869Pointcare Now SystemPointcare Technologies, Inc.200801
+2K071681Cytomics FC 500 MPL Flow Cytometer, Model # 626554Beckman Coulter, Inc.20071Class I
+3K183592ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow CytometerBeckman Coulter20191—
+3K162897Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser…Beckman Coulter20172—
+4K232600DxFLEX Flow Cytometer; ClearLLab 10C PanelsBeckman Coulter, Inc.202301