510(k) K123593 ยท LKP Anti-Sm Antibody, Antigen And Control
QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS,
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Apr 17, 2013 |
| Received | Nov 21, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123593
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.