510(k) K063655 ยท CHN Immunochemical, Ceruloplasmin
DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGH
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Feb 15, 2007 |
| Received | Dec 8, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063655
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.