510(k) K221114 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Immunoglobulin G (IgG)
| Applicant | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, Aug 2, 2023 |
| Received | Apr 15, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221114
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.