510(k) K062372 ยท DFH Kappa, Antigen, Antiserum, Control
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER
| Applicant | The Binding Site, Ltd., Santa Monica CA, US |
| Decision | Substantially Equivalent, Jun 21, 2007 |
| Received | Aug 14, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062372
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 19, 2017 | The Binding Site Group, Ltd. Human Lambda Free SPAPlus Kit
Product Code: LK018.S
Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases. Terminated |
DEH | None listed |
| Jan 19, 2017 | The Binding Site Group, Ltd. Freelite Human Lambda Free Kit for use on SPAPLUS
Product Code: LK018.S, LK018.10S
Freelite aids the detection and monitoring of Multiple Myeloma and related diseases Terminated |
DEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.