510(k) K091845 ยท MID System, Test, Anticardiolipin Immunological
CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM
| Applicant | Phadia US, Inc., Portage MI, US |
| Decision | Substantially Equivalent, Jun 7, 2010 |
| Received | Jun 22, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091845
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.