510(k) K993549 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN A (IGALC) REAGENT, BECKMAN COULTER CEREBR
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Feb 1, 2000 |
| Received | Oct 19, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993549
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.