510(k) K911680 ยท MID System, Test, Anticardiolipin Immunological
QUANTA LITE(TM) ACA
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Nov 19, 1991 |
| Received | Apr 15, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911680
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.