The following data is part of a premarket notification filed by Beckman Coulter Cellular with the FDA for Dxh 300 Coulter Cellular Analysis System, Dxh 300c Coulter Cellular Analyssi System Model: 71772, 71771.
| Device ID | K100489 |
| 510k Number | K100489 |
| Device Name: | DXH 300 COULTER CELLULAR ANALYSIS SYSTEM, DXH 300C COULTER CELLULAR ANALYSSI SYSTEM MODEL: 71772, 71771 |
| Classification | Counter, Differential Cell |
| Applicant | BECKMAN COULTER CELLULAR 11800 SW 147 AVENUE MS 31 BO6 Miami, FL 33196 -2500 |
| Contact | Jeanne Roscoe |
| Correspondent | Jeanne Roscoe BECKMAN COULTER CELLULAR 11800 SW 147 AVENUE MS 31 BO6 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 | 2010-02-19 |
| Decision Date | 2010-10-26 |
| Summary: | summary |