510(k) K151429 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Feb 12, 2016 |
| Received | May 28, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151429
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.