510(k) K140396 ยท DEH Lambda, Antigen, Antiserum, Control
FREELITE HUMAN LAMBDA FREE KIT
| Applicant | The Binding Site Group , Ltd., San Diego CA, US |
| Decision | Substantially Equivalent, Apr 16, 2014 |
| Received | Feb 18, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140396
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2021 | The Binding Site Group, Ltd. Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S
Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S Terminated |
DEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.