The following data is part of a premarket notification filed by Beckman Coulter with the FDA for Navios Ex Flow Cytometer, 6 Color/2 Laser, Navios Ex Flow Cytometer, 8 Color/2 Laser, Navios Ex Flow Cytometer, 10 Color/3 Laser.
| Device ID | K162897 |
| 510k Number | K162897 |
| Device Name: | Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser |
| Classification | Flow Cytometric Reagents And Accessories. |
| Applicant | BECKMAN COULTER 11800 SW 147TH AVE Miami, FL 33196 -2500 |
| Contact | Suzana Otano |
| Correspondent | Suzana Otano BECKMAN COULTER 11800 SW 147TH AVE Miami, FL 33196 -2500 |
| Product Code | OYE |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-17 |
| Decision Date | 2017-06-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590683276 | K162897 | 000 |
| 15099590683269 | K162897 | 000 |
| 15099590683252 | K162897 | 000 |
| 15099590683245 | K162897 | 000 |
| 15099590683009 | K162897 | 000 |
| 15099590682996 | K162897 | 000 |
| 15099590677466 | K162897 | 000 |