510(k) K150526 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Optilite IgG4 Kit
| Applicant | The Binding Site Group , Ltd., Birmingham, GB |
| Decision | Substantially Equivalent, May 30, 2015 |
| Received | Mar 2, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150526
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2016 | The Binding Site Group, Ltd. Optilite IgG4 Kit
Product Code: LK009.OPT.A Terminated |
CFN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.