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Beckman Coulter

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories5
Latest FDA decision2024-04-15
TypeNumberDevice NameCodeDateActions
510(k) K232904 Access OstaseCIN2024-04-15 View
510(k) K193124 Unicel DxH 800 Coulter Cellular Analysis SystemGKZ2020-04-16 View
510(k) K182886 Cytomics FC 500 Series (MPL or MCL) Flow CytometerGKZ2019-09-06 View
510(k) K183592 ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow CytometerPWD2019-03-21 View
510(k) K181599 Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator ApplicationQFS2019-03-18 View
510(k) K181475 DxH 520 Hematology InstrumentGKZ2019-03-01 View
510(k) K162897 Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 LaserOYE2017-06-23 View