510(k) K190428 ยท LOL Hepatitis A Test (Antibody And Igm Antibody)
Elecsys Anti-HAV II
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 13, 2019 |
| Received | Feb 22, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190428
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.