510(k) K152013 ยท LSW Anti-Dna Antibody, Antigen And Control
QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Apr 11, 2016 |
| Received | Jul 21, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152013
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.