510(k) K080751 ยท MKW Cyclosporine
ARCHITECT CYCLOSPORINE
| Applicant | Fujirebio Diagnostics,Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Sep 11, 2008 |
| Received | Mar 18, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080751
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2011 | Abbott Laboratories ARCHITECT Cyclosporine; an in-vitro diagnostic chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cyclosporine in human whole blood Distributed by Abbott Laborator Terminated |
MKW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.