K182353 is an FDA 510(k) clearance for the EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay. This device is classified as a Antinuclear Antibody (enzyme-labeled), Antigen, Controls (Class II - Special Controls, product code LJM).
Submitted by Phadia AB (Uppsala, SE). The FDA issued a Cleared decision on November 27, 2018, 90 days after receiving the submission on August 29, 2018.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K182353 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 2018 |
| Decision Date | November 27, 2018 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | LJM — Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |