510(k) K141328 ยท LLL Extractable Antinuclear Antibody, Antigen And Control
QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Feb 12, 2015 |
| Received | May 21, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141328
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.