510(k) K092355 ยท LOL Hepatitis A Test (Antibody And Igm Antibody)
MONOLISA ANTI-HAV EIA
| Applicant | Bio-Rad Laboratories, Inc., Redmond WA, US |
| Decision | Substantially Equivalent, Oct 29, 2009 |
| Received | Aug 4, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092355
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.