510(k) K982603 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
QUANTA LITE CHROMATIN ELISA
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Oct 7, 1998 |
| Received | Jul 27, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982603
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.