510(k) K180975 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
QUANTA Flash HMGCR Reagents
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jun 25, 2018 |
| Received | Apr 13, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180975
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.