K191562 is an FDA 510(k) clearance for the Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor. This device is classified as a Ferritin, Antigen, Antiserum, Control (Class II - Special Controls, product code DBF).
Submitted by HORIBA ABX SAS (Montpellier Cedex 4, FR). The FDA issued a Cleared decision on March 6, 2020, 267 days after receiving the submission on June 13, 2019.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5340.
| 510(k) Number | K191562 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 2019 |
| Decision Date | March 06, 2020 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DBF - Ferritin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5340 |