510(k) K983694 ยท MID System, Test, Anticardiolipin Immunological
ANTICARDIOLIPIN IGM 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 K983694
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2003 | Binding Site Inc The Bindazyme, Human AntiCardiolipin IgM Enzyme Immunoassay Kits, MK029 Terminated |
MID | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.