FDA Product Code
FDA Product Code OPX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5510
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K160819 | Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit | The Binding Site Group , Ltd. | 2016-06-16 | Traditional | PDF ↗ |
| K151759 | Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS | The Binding Site Group , Ltd. | 2015-11-06 | Traditional | PDF ↗ |
| K140105 | HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII | The Binding Site | 2014-03-18 | Traditional | PDF ↗ |
Product code OPX · Class II · Immunology. Data: openFDA.