The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Automated Differential Cell Counter.
| Device ID | BK010044 |
| 510k Number | BK010044 |
| 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) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-16 |
| Decision Date | 2002-05-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590559519 | BK010044 | 0 |
| 15099590220020 | BK010044 | 0 |
| 15099590220013 | BK010044 | 0 |