510(k) K032860 ยท NBT Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA)
| Applicant | Immco Diagnostics, Inc., Buffalo NY, US |
| Decision | Substantially Equivalent, Mar 18, 2004 |
| Received | Sep 12, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032860
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.