K201814 is an FDA 510(k) clearance for the 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. This device is classified as a Flow Cytometric Reagents And Accessories. (Class II - Special Controls, product code OYE).
Submitted by Becton, Dickinson and Company (San Jose, US). The FDA issued a Cleared decision on September 28, 2020, 89 days after receiving the submission on July 1, 2020.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 864.5220. 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..
| 510(k) Number | K201814 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2020 |
| Decision Date | September 28, 2020 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | OYE — Flow Cytometric Reagents And Accessories. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5220 |
| 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. |