510(k) K970177 ยท MID System, Test, Anticardiolipin Immunological
ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA
| Applicant | Immco Diagnostics, Inc., Buffalo NY, US |
| Decision | Substantially Equivalent, Jun 11, 1997 |
| Received | Jan 17, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970177
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.