510(k) K220085 ยท OIF Tyrosine Phosphatase (Ia-2) Autoantibody Assay
KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
| Applicant | Kronus, Inc., Star ID, US |
| Decision | Substantially Equivalent, Aug 24, 2023 |
| Received | Jan 11, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220085
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.