510(k) K243846 ยท LOL Hepatitis A Test (Antibody And Igm Antibody)
Access anti-HAV
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Sep 9, 2025 |
| Received | Dec 16, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243846
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.