510(k) K061845 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
DIMENSION VISTA IGM FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Aug 24, 2006 |
| Received | Jun 29, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061845
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.