The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Automated Differential Cell Counter.
| Device ID | BK040055 |
| 510k Number | BK040055 |
| Device Name: | Automated Differential Cell Counter |
| Classification | Counter, Differential Cell |
| Applicant | Beckman Coulter, Inc. 11800 Sw 147 Avenue (m/c: 31-b06) Miami, FL 33196 US |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Abbrevia |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-21 |
| Decision Date | 2004-09-16 |