510(k) K920401 ยท MID System, Test, Anticardiolipin Immunological
IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST
| Applicant | General Biometrics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Aug 20, 1992 |
| Received | Jan 29, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K920401
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.