510(k) K173732 ยท DFH Kappa, Antigen, Antiserum, Control
Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit
| Applicant | The Binding Site Group , Ltd., Birmingham, GB |
| Decision | Substantially Equivalent, Aug 23, 2018 |
| Received | Dec 6, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173732
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2020 | The Binding Site Group, Ltd. Optilite Freelite Mx Kappa Free Kit
REF LK016.M.OPT.A Terminated |
DFH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.