510(k) K192116 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Human IgA liquid reagent kit for Use on SPAPlus
| Applicant | The Binding Site Group , Ltd., Birmingham, GB |
| Decision | Substantially Equivalent, Sep 4, 2019 |
| Received | Aug 6, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192116
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.