510(k) K020156 ยท MID System, Test, Anticardiolipin Immunological
DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T
| Applicant | Axis-Shield Diagnostics, Ltd., Dundee, Scotland, GB |
| Decision | Substantially Equivalent, Mar 6, 2002 |
| Received | Jan 17, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020156
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.