510(k) DEN000007 ยท NBT Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Unknown, Aug 16, 2000 |
| Received | Jul 18, 2000 |
| Type | Post-NSE |
| FDA record | Open on fda.gov |
Recalls that name DEN000007
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.