510(k) K052017 ยท MKW Cyclosporine
CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108
| Applicant | Dade Behring, Inc., P.O. Box 6101, Newark DE, US |
| Decision | Substantially Equivalent, Sep 1, 2005 |
| Received | Jul 26, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052017
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.