510(k) K961913 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
QUANTA LITE ENA 6 ELISA
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jul 10, 1996 |
| Received | May 17, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961913
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.