The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Unicel Dxh 800 Coulter Cellular Analysis System.
| Device ID | K120771 |
| 510k Number | K120771 |
| Device Name: | UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM |
| Classification | Counter, Differential Cell |
| Applicant | BECKMAN COULTER, INC. 11800 SW 147TH AVE. Miami, FL 33196 -2500 |
| Contact | Eric Grace |
| Correspondent | Eric Grace BECKMAN COULTER, INC. 11800 SW 147TH AVE. Miami, FL 33196 -2500 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-14 |
| Decision Date | 2013-03-22 |
| Summary: | summary |