The following data is part of a premarket notification filed by Delcon S.r.l with the FDA for Blood Mixing Device, Semi-automated.
| Device ID | BK180229 |
| 510k Number | BK180229 |
| Device Name: | Blood Mixing Device, Semi-automated |
| Classification | Device, Mixing And Weighing, Semi-automated |
| Applicant | Delcon S.R.L via Zanica Grassobbio, BG, 24050, IT |
| Product Code | MYJ |
| CFR Regulation Number | 864.9195 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-10 |
| Decision Date | 2018-10-04 |