Panels › Immunology › Product code OPX · Class 2
Immunoglobulin A Kappa Heavy & Light Chain Combined
Regulation 866.5510
0510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OPX
| Company | 510(k)s | Recalls |
|---|---|---|
| The Binding Site Group , Ltd. | 2 | 0 |
| The Binding Site | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 16, 2016 | K160819 | Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit The Binding Site Group , Ltd., GB | OPX |
| Nov 6, 2015 | K151759 | Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS The Binding Site Group , Ltd., GB | OPX |
| Mar 18, 2014 | K140105 | HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII The Binding Site, GB | OPX |
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