510(k) K081249 ยท DEB Alpha-2-Macroglobulin, Antigen, Antiserum, Control
DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Jul 21, 2008 |
| Received | May 2, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081249
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.