510(k) K113020 ยท MID System, Test, Anticardiolipin Immunological
IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS
| Applicant | Immco Diagnostics, Inc., Buffalo NY, US |
| Decision | Substantially Equivalent, Oct 25, 2012 |
| Received | Oct 11, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113020
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.