K202067 is an FDA 510(k) clearance for the EliA SmDP-S. This device is classified as a Anti-sm Antibody, Antigen And Control (Class II - Special Controls, product code LKP).
Submitted by Phadia AB (Uppsala, SE). The FDA issued a Cleared decision on July 14, 2021, 352 days after receiving the submission on July 27, 2020.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K202067 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 2020 |
| Decision Date | July 14, 2021 |
| Days to Decision | 352 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | LKP — Anti-sm Antibody, Antigen And Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |