510(k) K202541 ยท NYO Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody
EliA RNA Pol III
| Applicant | Phadia AB, Uppsala, SE |
| Decision | Substantially Equivalent, Sep 13, 2021 |
| Received | Sep 2, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202541
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.