510(k) K152635 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jun 1, 2016 |
| Received | Sep 15, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152635
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.