510(k) K161297 ยท JZG System, Test, Beta-2-Microglobulin Immunological
Beta-2-Microglobulin
| Applicant | Beckman Coulter Ireland, Inc., Co. Clare, IE |
| Decision | Substantially Equivalent, Jun 7, 2016 |
| Received | May 9, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161297
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.