510(k) K983695 ยท MID System, Test, Anticardiolipin Immunological
ANTICARDIOLIPIN IGGAM SCREEN EIA DIAGNOSTIC TEST KIT
| Applicant | The Binding Site, Ltd., Santa Monica CA, US |
| Decision | Substantially Equivalent, Feb 5, 1999 |
| Received | Oct 21, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983695
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.