Panels › Immunology › Product code PDE · Class 2
Immunoglobulin M Kappa Heavy And Light Chain Combined
Regulation 866.5510
0510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PDE
| Company | 510(k)s | Recalls |
|---|---|---|
| The Binding Site Group , Ltd. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 18, 2015 | K152389 | Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit The Binding Site Group , Ltd., GB | PDE |
| Aug 6, 2014 | K140686 | HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS The Binding Site Group , Ltd., GB | PDE |
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