510(k) K191985 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Optilite IgA Kit
| Applicant | The Binding Site Group , Ltd., Edgbaston, GB |
| Decision | Substantially Equivalent, Aug 19, 2019 |
| Received | Jul 25, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191985
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.