510(k) K020758 ยท MID System, Test, Anticardiolipin Immunological
VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696
| Applicant | Pharmacia Deutschland GmbH, Freiburg, DE |
| Decision | Substantially Equivalent, May 2, 2002 |
| Received | Mar 7, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020758
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 28, 2012 | Phadia US Inc PHADIA Varelisa Cardiolipin IgM
Cardiolipin autoantibody immunological test system (IgM class antibodies) Terminated |
MID | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.