510(k) K122066 ยท JZG System, Test, Beta-2-Microglobulin Immunological
HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS
| Applicant | The Binding Site Group , Ltd., Birmingham, GB |
| Decision | Substantially Equivalent, Aug 30, 2012 |
| Received | Jul 16, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122066
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 9, 2018 | The Binding Site Group, Ltd. Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Birmingham, U.K.
The Optilite Beta-2-Microglobulin (2M) Urine Terminated |
JZG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.