The following data is part of a premarket notification filed by Fenwal Inc with the FDA for Automated Blood Cell Separators.
| Device ID | BK040059 |
| 510k Number | BK040059 |
| Device Name: | Automated Blood Cell Separators |
| Classification | Separator, Automated, Blood Cell, Diagnostic |
| Applicant | Fenwal Inc three Corporate Drive Lake Zurich, IL 60047 |
| Product Code | GKT |
| CFR Regulation Number | 864.9245 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-13 |
| Decision Date | 2004-09-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04086000101349 | BK040059 | 0 |
| 04086000101332 | BK040059 | 0 |
| 04086000101325 | BK040059 | 0 |