510(k) Report

Devices descending from K030828

6 later devices reach Tetracxp System (Software and System Guide) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182886Cytomics FC 500 Series (MPL or MCL) Flow CytometerBeckman Coulter20190—
+1K130373Navios Flow Cytometer SystemBeckman Coulter, Inc.20133—
+1K071681Cytomics FC 500 MPL Flow Cytometer, Model # 626554Beckman Coulter, Inc.20071Class I
+2K183592ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow CytometerBeckman Coulter20191—
+2K162897Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser…Beckman Coulter20172—
+3K232600DxFLEX Flow Cytometer; ClearLLab 10C PanelsBeckman Coulter, Inc.202301