510(k) K012053 ยท MID System, Test, Anticardiolipin Immunological
DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM
| Applicant | Diamedix Corp., Miami FL, US |
| Decision | Substantially Equivalent, Aug 20, 2001 |
| Received | Jul 2, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012053
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.