Panels › Hematology › Product code OYE · Class 2
Flow Cytometric Reagents And Accessories.
Regulation 864.5220
1510(k)s in 12 months (9 all time)
1recalls in 12 months (26 all time)
25recalls that name a 510(k)
Top companies in OYE
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 20, 2026 | K260215 | BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5) Bd Biosciences | OYE |
| Nov 22, 2023 | K232600 | DxFLEX Flow Cytometer; ClearLLab 10C Panels Beckman Coulter, Inc. | OYE |
| Sep 28, 2020 | K201814 | BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation Sy Becton, Dickinson and Company | OYE |
| Jul 3, 2017 | K170974 | BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multit Becton, Dickinson and Company | OYE |
| Jun 23, 2017 | K162897 | Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color Beckman Coulter | OYE |
| Apr 10, 2015 | K141932 | AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS Beckman Coulter, Inc. | OYE |
| Feb 27, 2015 | K141468 | BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration) Bd Biosciences | OYE |
| Sep 18, 2013 | K130373 | NAVIOS FLOW CYTOMETER SYSTEM Beckman Coulter, Inc. | OYE |
| Jul 26, 2013 | K121445 | TETRACHROME REAGENTS AND TETRACXP SYSTEM Beckman Coulter, Inc. | OYE |
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