510(k) K191465 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Human IgM Kit for use on SPAPlus
| Applicant | The Binding Site Group , Ltd., Edgbaston, GB |
| Decision | Substantially Equivalent, Jun 27, 2019 |
| Received | Jun 3, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191465
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 29, 2019 | The Binding Site Group, Ltd. OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565 Terminated |
CFN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.