510(k) K052015 ยท DLJ Calibrators, Drug Specific
DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Sep 12, 2005 |
| Received | Jul 26, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052015
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.