510(k) K192916 ยท KTL Anti-Dna Indirect Immunofluorescent Solid Phase
NOVA Lite DAPI dsDNA Crithidia luciliae Kit
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Dec 11, 2020 |
| Received | Oct 15, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192916
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.