510(k) K000733 ยท NBT Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, May 21, 2001 |
| Received | Mar 6, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000733
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.