K190298 is an FDA 510(k) clearance for the DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12. This device is classified as a Radioassay, Vitamin B12 (Class II - Special Controls, product code CDD).
Submitted by Beckman Coulter Biomedical GmbH (Munich, DE). The FDA issued a Cleared decision on October 4, 2019, 235 days after receiving the submission on February 11, 2019.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1810.
| 510(k) Number | K190298 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 2019 |
| Decision Date | October 04, 2019 |
| Days to Decision | 235 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CDD - Radioassay, Vitamin B12 |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1810 |