510(k) K190686 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Optilite IgM CSF Kit
| Applicant | The Binding Site Group , Ltd., Edgbaston, GB |
| Decision | Substantially Equivalent, May 28, 2019 |
| Received | Mar 18, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190686
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.