K190710 is an FDA 510(k) clearance for the EliA SymphonyS Immunoassay. This device is classified as a Extractable Antinuclear Antibody, Antigen And Control (Class II - Special Controls, product code LLL).
Submitted by Phadia AB (Uppsala, SE). The FDA issued a Cleared decision on November 29, 2019, 255 days after receiving the submission on March 19, 2019.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K190710 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 19, 2019 |
| Decision Date | November 29, 2019 |
| Days to Decision | 255 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | LLL — Extractable Antinuclear Antibody, Antigen And Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |