The following data is part of a premarket notification filed by Beckman Coulter with the FDA for Unicel Dxh 800 Cellular Analysis System With Early Sepsis Indicator Application.
| Device ID | K181599 |
| 510k Number | K181599 |
| Device Name: | Unicel DxH 800 Cellular Analysis System With Early Sepsis Indicator Application |
| Classification | Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment |
| Applicant | Beckman Coulter 11800 SW 147th Ave Miami, FL 33196 -2500 |
| Contact | Radha Goolabsingh |
| Correspondent | Radha Goolabsingh Beckman Coulter 11800 SW 147th Ave Miami, FL 33196 -2500 |
| Product Code | QFS |
| CFR Regulation Number | 866.3215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-18 |
| Decision Date | 2019-03-18 |