510(k) K946385 ยท MID System, Test, Anticardiolipin Immunological
QUANTA LITE ACA IGM (HRP)
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jul 18, 1995 |
| Received | Dec 9, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946385
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.