510(k) K162208 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Jan 9, 2017 |
| Received | Aug 5, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162208
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.