K202540 is an FDA 510(k) clearance for the EliA Rib-P. This device is classified as a Anti-ribosomal P Antibodies (Class II - Special Controls, product code MQA).
Submitted by Phadia AB (Uppsala, SE). The FDA issued a Cleared decision on September 13, 2021, 376 days after receiving the submission on September 2, 2020.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K202540 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 2020 |
| Decision Date | September 13, 2021 |
| Days to Decision | 376 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | MQA — Anti-ribosomal P Antibodies |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |