510(k) K130122 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Jan 7, 2014 |
| Received | Jan 17, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130122
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.