The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Counter, Differential Cell.
| Device ID | BK210639 |
| 510k Number | BK210639 |
| Device Name: | Counter, Differential Cell |
| Classification | Counter, Differential Cell |
| Applicant | Beckman Coulter, Inc. 11800 Sw 147 Avenue (m/c: 31-b06) Miami, FL 33196 2500 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-15 |
| Decision Date | 2021-12-15 |