FDA Product Code
FDA Product Code OYE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.5220
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K232600 | DxFLEX Flow Cytometer; ClearLLab 10C Panels | Beckman Coulter, Inc. | 2023-11-22 | Traditional | PDF ↗ |
| 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 System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit | Becton, Dickinson and Company | 2020-09-28 | Traditional | PDF ↗ |
| K170974 | BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK | Becton, Dickinson and Company | 2017-07-03 | Traditional | PDF ↗ |
| K162897 | 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 | 2017-06-23 | Traditional | PDF ↗ |
| K141932 | AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS | Beckman Coulter, Inc. | 2015-04-10 | Traditional | PDF ↗ |
| K141468 | BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration) | Bd Biosciences | 2015-02-27 | Traditional | PDF ↗ |
| K130373 | NAVIOS FLOW CYTOMETER SYSTEM | Beckman Coulter, Inc. | 2013-09-18 | Traditional | PDF ↗ |
| K121445 | TETRACHROME REAGENTS AND TETRACXP SYSTEM | Beckman Coulter, Inc. | 2013-07-26 | Special | PDF ↗ |
Product code OYE · Class II · Hematology. Data: openFDA.