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
FDA 510(k) clearance K201814 · decided 2020-09-28
Clearance details
- K-number
- K201814
- Device name
- 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
- Applicant
- Becton, Dickinson and Company
- Decision
- Substantially Equivalent
- Date received
- 2020-07-01
- Decision date
- 2020-09-28
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- OYE
- Device class
- 2
- Regulation number
- 864.5220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| DxFLEX Flow Cytometer; ClearLLab 10C Panels (K232600) | Beckman Coulter, Inc. | 2023-11-22 |
| 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 (K170974) | Becton, Dickinson and Company | 2017-07-03 |
| Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser (K162897) | Beckman Coulter | 2017-06-23 |
| AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS (K141932) | Beckman Coulter, Inc. | 2015-04-10 |
| BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration) (K141468) | Bd Biosciences | 2015-02-27 |
| NAVIOS FLOW CYTOMETER SYSTEM (K130373) | Beckman Coulter, Inc. | 2013-09-18 |
| TETRACHROME REAGENTS AND TETRACXP SYSTEM (K121445) | Beckman Coulter, Inc. | 2013-07-26 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FACSLyric" flow recall (Z-0745-2025) | Becton, Dickinson and Company, BD Bio Sciences | 2024-12-23 |
| Device Description: FACSLyric 2L6C Instrument US, Catalog Number 662876, UDI 0038290662876 recall (Z-0746-2025) | Becton, Dickinson and Company, BD Bio Sciences | 2024-12-23 |
| FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770 The K170974 cl recall (Z-0747-2025) | Becton, Dickinson and Company, BD Bio Sciences | 2024-12-23 |
| FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787 The K170974 c recall (Z-0748-2025) | Becton, Dickinson and Company, BD Bio Sciences | 2024-12-23 |
| FACSLyric 3L12C Instrument RUO, Catalog Number 663518, UDI 00382906635181 recall (Z-0749-2025) | Becton, Dickinson and Company, BD Bio Sciences | 2024-12-23 |
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| BD ONCLARITY HPV ASSAY (P160037/S022) | Becton, Dickinson and Company | 2025-08-25 |
| BD Onclarity HPV Assay (P160037/S023) | Becton, Dickinson and Company | 2025-07-02 |
| Onclarity HPV Assay (P160037/S021) | Becton, Dickinson and Company | 2025-03-12 |
| BD Onclarity HPV Assay (P160037/S020) | Becton, Dickinson and Company | 2024-11-05 |
| BD Onclarity HPV Assay (P160037/S017) | Becton, Dickinson and Company | 2024-05-14 |