510(k) K032240 ยท MID System, Test, Anticardiolipin Immunological
BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT
| Applicant | The Binding Site, Ltd., Santa Monica CA, US |
| Decision | Substantially Equivalent, Sep 29, 2003 |
| Received | Jul 21, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032240
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.