The Binding Site · Class II · Cleared Mar 18, 2014
| K-number | K140105 |
| Device name | HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII |
| Applicant | The Binding Site |
| Product code | OPX |
| Device class | Class II |
| Decision date | Mar 18, 2014 |
| Decision | Substantially Equivalent |
| Regulation | 866.5510 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov