510(k) K042579 ยท NBT Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT
| Applicant | The Binding Site, Santa Monica CA, US |
| Decision | Substantially Equivalent, Jul 28, 2005 |
| Received | Sep 22, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042579
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.