510(k) K150658 ยท DFH Kappa, Antigen, Antiserum, Control
Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit
| Applicant | The Binding Site Group , Ltd., Birmingham, GB |
| Decision | Substantially Equivalent, Aug 26, 2015 |
| Received | Mar 13, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150658
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 18, 2017 | The Binding Site Group, Ltd. Optilite Freelite Lambda Free Kit
Product Code: LK018.OPT, LK018.OPT.A
Protein testing kit. Terminated |
DEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.