K210902 is an FDA 510(k) clearance for the EliA Ro52, EliA Ro60. This device is classified as a Antinuclear Antibody, Antigen, Control (Class II - Special Controls, product code LKJ).
Submitted by Phadia AB (Uppsala, SE). The FDA issued a Cleared decision on July 27, 2022, 488 days after receiving the submission on March 26, 2021.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K210902 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 2021 |
| Decision Date | July 27, 2022 |
| Days to Decision | 488 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | LKJ — Antinuclear Antibody, Antigen, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |