OYE — Flow Cytometric Reagents And Accessories. Class II
Classification Details
- Product Code
- OYE
- Device Class
- Class II
- Regulation Number
- 864.5220
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Definition
To identify and classify cells or other particles in suspension by their inherent physical properties or associated fluorescent molecules in order to provide information about the distribution or number cells in suspension or their level of protein expression. These characteristics may aid in the diagnosis of conditions such as immunodeficiency and cancer.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K232600 | beckman coulter | DxFLEX Flow Cytometer; ClearLLab 10C Panels | November 22, 2023 |
| K201814 | becton, dickinson and | BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurat | September 28, 2020 |
| K170974 | becton, dickinson and | BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), | July 3, 2017 |
| K162897 | beckman coulter | Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 L | June 23, 2017 |
| K141932 | beckman coulter | AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMU | April 10, 2015 |
| K141468 | bd biosciences | BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow | February 27, 2015 |
| K130373 | beckman coulter | NAVIOS FLOW CYTOMETER SYSTEM | September 18, 2013 |
| K121445 | beckman coulter | TETRACHROME REAGENTS AND TETRACXP SYSTEM | July 26, 2013 |