510(k) K073561 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Feb 26, 2008 |
| Received | Dec 19, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073561
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.