510(k) K954380 ยท LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
QUANTA LITE SSDNA
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Feb 29, 1996 |
| Received | Sep 19, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954380
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.