510(k) K081161 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Jul 28, 2008 |
| Received | Apr 24, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081161
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.