FDA Product Code
FDA Product Code PCN — 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 |
|---|---|---|---|---|---|
| K172613 | Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit | The Binding Site Group , Ltd. | 2018-02-15 | Traditional | PDF ↗ |
| K161854 | Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS | The Binding Site Group , Ltd. | 2016-10-04 | Traditional | PDF ↗ |
| K132555 | HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT | The Binding Site | 2013-12-20 | Traditional | PDF ↗ |
Product code PCN · Class II · Immunology. Data: openFDA.