| Device ID | BK180188 |
| 510k Number | BK180188 |
| Device Name: | Empty Containers For The Collection & Processing Of Blood/Blood Components |
| Classification | Container, Empty, For Collection & Processing Of Blood & Blood Components |
| Applicant | PuriBlood Medical Co. Ltd. 2f., No.11, Gongye E. 9th Rd. paoshan Hsiang Hsinchu Hsien, 30075, TW |
| 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 | 2018-02-28 |
| Decision Date | 2018-11-23 |