510(k) K100903 ยท LOL Hepatitis A Test (Antibody And Igm Antibody)
ANTI-HAV
| Applicant | Roche Professional Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Oct 5, 2010 |
| Received | Apr 1, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100903
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.