The following data is part of a premarket notification filed by Biosystems S.a. with the FDA for Transferrin.
| Device ID | K190495 |
| 510k Number | K190495 |
| Device Name: | Transferrin |
| Classification | Transferrin, Antigen, Antiserum, Control |
| Applicant | BioSystems S.A. Costa Brava, 30 Barcelona, ES 08030 |
| Contact | Noelia Gil |
| Correspondent | Noelia Gil BioSystems S.A. Costa Brava, 30 Barcelona, ES 08030 |
| Product Code | DDG |
| CFR Regulation Number | 866.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-28 |
| Decision Date | 2020-03-16 |