510(k) K141210 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jan 29, 2015 |
| Received | May 9, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141210
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.