The following data is part of a premarket notification filed by Terumo Bct, Inc with the FDA for Semi-automated Blood Component Separator.
| Device ID | BK080010 |
| 510k Number | BK080010 |
| Device Name: | Semi-automated Blood Component Separator |
| Classification | Separator, Semi-automated, Blood Component |
| Applicant | Terumo BCT, Inc 10811 W. Collins Ave. Lakewood, CO 80215 US |
| Product Code | MYY |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-13 |
| Decision Date | 2008-06-27 |