510(k) K003959 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jan 22, 2001 |
| Received | Dec 21, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003959
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.