The following data is part of a premarket notification filed by Haemonetics Corporation with the FDA for Automated Blood Cell Separators.
| Device ID | BK050047 |
| 510k Number | BK050047 |
| Device Name: | Automated Blood Cell Separators |
| Classification | Separator, Automated, Blood Cell, Diagnostic |
| Applicant | Haemonetics Corporation 400 Wood Road Braintree, MA 02184 |
| 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 | 2005-08-31 |
| Decision Date | 2005-11-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30812747012854 | BK050047 | 0 |
| 30812747012816 | BK050047 | 0 |
| 30812747012861 | BK050047 | 0 |