K182747 is an FDA 510(k) clearance for the EliA RF IgM Immunoassay. This device is classified as a System, Test, Rheumatoid Factor (Class II - Special Controls, product code DHR).
Submitted by Phadia AB (Uppsala, SE). The FDA issued a Cleared decision on December 18, 2018, 81 days after receiving the submission on September 28, 2018.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5775.
| 510(k) Number | K182747 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2018 |
| Decision Date | December 18, 2018 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DHR — System, Test, Rheumatoid Factor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5775 |