510(k) K063425 ยท DGC Ige, Antigen, Antiserum, Control
DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Feb 15, 2007 |
| Received | Nov 13, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063425
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.