FDA Product Code
FDA Product Code PDE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5510
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K152389 | Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit | The Binding Site Group , Ltd. | 2015-12-18 | Traditional | PDF ↗ |
| K140686 | HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS | The Binding Site Group , Ltd. | 2014-08-06 | Traditional | PDF ↗ |
Product code PDE · Class II · Immunology. Data: openFDA.