K183007 is an FDA 510(k) clearance for the EliA SmDP Immunoassay. 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 December 24, 2018, 54 days after receiving the submission on October 31, 2018.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K183007 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2018 |
| Decision Date | December 24, 2018 |
| Days to Decision | 54 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 |