510(k) K070820 ยท MLM Enzyme Immunoassay, Tracrolimus
ARCHITECT TACROLIMUS: MODEL 1L77
| Applicant | Fujirebio Diagnostics,Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Aug 1, 2007 |
| Received | Mar 26, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070820
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2010 | Abbott Laboratories Architect Tacrolimus Reagent Kit; an in-vitro diagnostic chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of tacrolimus in human whole blood; Abbott Laboratories, A Terminated |
MLM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.