510(k) K183151 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Optilite IgA CSF Kit
| Applicant | The Binding Site Group , Ltd., Birmingham, GB |
| Decision | Substantially Equivalent, Jan 23, 2019 |
| Received | Nov 14, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183151
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.