510(k) K190088 ยท DHR System, Test, Rheumatoid Factor
QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Apr 17, 2019 |
| Received | Jan 17, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190088
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.