The following data is part of a premarket notification filed by Cobe Cardiovascular, Inc. with the FDA for Automated Blood Cell Separators.
| Device ID | BK970023 |
| 510k Number | BK970023 |
| Device Name: | Automated Blood Cell Separators |
| Classification | Separator, Automated, Blood Cell, Diagnostic |
| Applicant | COBE Cardiovascular, Inc. 1201 Oak Street Lakewood, CO 80215 |
| 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 | 1997-07-16 |
| Decision Date | 1998-10-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05020583810020 | BK970023 | 0 |
| 05020583810013 | BK970023 | 0 |
| 05020583810006 | BK970023 | 0 |