K162897 is an FDA 510(k) clearance for the Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser. This device is classified as a Flow Cytometric Reagents And Accessories. (Class II - Special Controls, product code OYE).
Submitted by Beckman Coulter (Miami, US). The FDA issued a Cleared decision on June 23, 2017, 249 days after receiving the submission on October 17, 2016.
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 | K162897 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 17, 2016 |
| Decision Date | June 23, 2017 |
| Days to Decision | 249 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. |