510(k) K172078 ยท NYO Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody
ImmuLisa Enhanced RNA POL III Antibody ELISA
| Applicant | Immco Diagnostics, Inc., Buffalo NY, US |
| Decision | Substantially Equivalent, Mar 30, 2018 |
| Received | Jul 10, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172078
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.