510(k) K063610 ยท DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control
DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Jan 11, 2007 |
| Received | Dec 4, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063610
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.