510(k) K921265 ยท MID System, Test, Anticardiolipin Immunological
DIASTAT ANTI-CARDIOLIPIN KIT
| Applicant | Shield Diagnostics, Ltd., Dundee, GB |
| Decision | Substantially Equivalent, Aug 3, 1992 |
| Received | Mar 16, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921265
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.