510(k) K012450 ยท MID System, Test, Anticardiolipin Immunological
DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM
| Applicant | Diamedix Corp., Miami FL, US |
| Decision | Substantially Equivalent, Oct 26, 2001 |
| Received | Aug 1, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012450
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.