The following data is part of a premarket notification filed by R & D Systems, Inc with the FDA for Automated Differential Cell Counter.
| Device ID | BK000036 |
| 510k Number | BK000036 |
| Device Name: | Automated Differential Cell Counter |
| Classification | Counter, Differential Cell |
| Applicant | R & D Systems, Inc 614 Mckinley Place N.e. Minneapolis, MN 55413 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 | 2000-07-31 |
| Decision Date | 2000-12-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590639402 | BK000036 | 0 |
| 00382903410026 | BK000036 | 000 |