510(k) K063318 ยท LOL Hepatitis A Test (Antibody And Igm Antibody)
MONOLISA ANTI-HAV EIA
| Applicant | Bio-Rad Laboratories, Hauts-De-Seine, FR |
| Decision | Substantially Equivalent, May 3, 2007 |
| Received | Nov 2, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063318
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.