FDA 510(k) Applications Submitted by BECKMAN COULTER
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| DEN160047 |
10/03/2016 |
ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M |
Beckman Coulter |
| K183592 |
12/21/2018 |
ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer |
Beckman Coulter |
| K181599 |
06/18/2018 |
Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application |
Beckman Coulter |
| K181475 |
06/04/2018 |
DxH 520 Hematology Instrument |
Beckman Coulter |
| K182886 |
10/15/2018 |
Cytomics FC 500 Series (MPL or MCL) Flow Cytometer |
Beckman Coulter |
| K193124 |
11/12/2019 |
Unicel DxH 800 Coulter Cellular Analysis System |
Beckman Coulter |
| K162897 |
10/17/2016 |
Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser |
BECKMAN COULTER |
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