The following data is part of a premarket notification filed by Origen Biomedical with the FDA for Empty Containers For The Collection & Processing Of Blood/blood Components.
| Device ID | BK180278 |
| 510k Number | BK180278 |
| Device Name: | Empty Containers For The Collection & Processing Of Blood/Blood Components |
| Classification | Container, Empty, For Collection & Processing Of Blood & Blood Components |
| Applicant | OriGen BioMedical 7000 Burleson Road, Building D Austin, TX 78744 US |
| Product Code | KSR |
| CFR Regulation Number | 864.9100 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-26 |
| Decision Date | 2018-11-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20816203023586 | BK180278 | 0 |
| 20816203023579 | BK180278 | 0 |
| 20816203023562 | BK180278 | 0 |
| 20816203023555 | BK180278 | 0 |