510(k) K001981 ยท MID System, Test, Anticardiolipin Immunological
DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500
| Applicant | Axis-Shield , Ltd., Dundee, GB |
| Decision | Substantially Equivalent, Aug 21, 2000 |
| Received | Jun 29, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001981
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 25, 2005 | Diasorin Inc. DiaSorin Anti-Cardiolipin IgA ELISA Kit, catalog no. 7800. Manufactured for: DiaSorin Inc. 1951 Northwestern Avenue, Stillwater, MN 55082. Made in the United Kingdom. Terminated |
MID | None listed |
| Mar 18, 2005 | Diasorin Inc. DiaSorin Anti-Cardiolipin IgA ELISA kit for the detection in human serum or plasma of antoantibodies specific for Cardiolipin IgA. Catalog No.: 7800. Manufactured for DiaSorin Inc., 1951 Northwester Terminated |
MID | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.