The following data is part of a premarket notification filed by Beckman Coulter with the FDA for Dxh 520 Hematology Instrument.
| Device ID | K181475 |
| 510k Number | K181475 |
| Device Name: | DxH 520 Hematology Instrument |
| 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 | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-04 |
| Decision Date | 2019-03-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590679781 | K181475 | 000 |
| 15099590671242 | K181475 | 000 |