The following data is part of a premarket notification filed by Beckman Coulter with the FDA for Unicel Dxh 800 Coulter Cellular Analysis System.
| Device ID | K193124 |
| 510k Number | K193124 |
| Device Name: | Unicel DxH 800 Coulter Cellular Analysis System |
| Classification | Counter, Differential Cell |
| Applicant | Beckman Coulter 11800 SW 147th Ave Miami, FL 33196 -2500 |
| Contact | Samy Puccio |
| Correspondent | Samy Puccio Beckman Coulter 11800 SW 147th Ave Miami, FL 33196 -2500 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-12 |
| Decision Date | 2020-04-16 |