The Binding Site, Ltd. · Class II · Cleared Jan 30, 2004
| K-number | K033811 |
| Device name | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER |
| Applicant | The Binding Site, Ltd. |
| Product code | DEH |
| Device class | Class II |
| Decision date | Jan 30, 2004 |
| Decision | Substantially Equivalent |
| Regulation | 866.5550 |
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