The following data is part of a premarket notification filed by Terumo Bct, Inc with the FDA for Container, Empty, For The Collection '& Processing Of Blood/blood Components.
| Device ID | BK210658 |
| 510k Number | BK210658 |
| Device Name: | Container, Empty, For The Collection '& Processing Of Blood/Blood Components |
| Classification | Container, Empty, For Collection & Processing Of Blood & Blood Components |
| Applicant | Terumo BCT, Inc 10811 W. Collins Ave. Lakewood, CO 80215 |
| Product Code | KSR |
| CFR Regulation Number | 864.9100 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-02 |
| Decision Date | 2022-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05020583419506 | BK210658 | 0 |