The following data is part of a premarket notification filed by Fenwal Inc with the FDA for Automated Blood Cell Separator -filtration.
| Device ID | BK010033 |
| 510k Number | BK010033 |
| Device Name: | Automated Blood Cell Separator -Filtration |
| 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 | 2001-09-04 |
| Decision Date | 2002-08-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10811137010124 | BK010033 | 0 |
| 04086000100212 | BK010033 | 0 |
| 04086000100199 | BK010033 | 0 |