K190495 is an FDA 510(k) clearance for the Transferrin. This device is classified as a Transferrin, Antigen, Antiserum, Control (Class II - Special Controls, product code DDG).
Submitted by Biosystems S.A. (Barcelona, ES). The FDA issued a Cleared decision on March 16, 2020, 382 days after receiving the submission on February 28, 2019.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5880.
| 510(k) Number | K190495 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2019 |
| Decision Date | March 16, 2020 |
| Days to Decision | 382 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DDG - Transferrin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5880 |