510(k) K120817 ยท MID System, Test, Anticardiolipin Immunological
QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Feb 26, 2013 |
| Received | Mar 19, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120817
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.