510(k) K162897
K162897 is an FDA 510(k) premarket notification submitted by Beckman Coulter for the device "Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser". The FDA issued a decision of Substantially Equivalent on June 23, 2017. The device falls under product code OYE (Flow Cytometric Reagents And Accessories.), a Class II device regulated under 21 CFR 864.5220. Beckman Coulter has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 2017
- Date Received
- October 17, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Flow Cytometric Reagents And Accessories.
- Device Class
- Class II
- Regulation Number
- 864.5220
- Review Panel
- HE
- Submission Type
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.