The following data is part of a premarket notification filed by Sentinel Ch. Spa with the FDA for Kappa Light Chains.
| Device ID | K083602 |
| 510k Number | K083602 |
| Device Name: | KAPPA LIGHT CHAINS |
| Classification | Kappa, Antigen, Antiserum, Control |
| Applicant | SENTINEL CH. SpA Via Robert Koch, 2 Milano, IT 20152 |
| Contact | Yangtse Portelles |
| Correspondent | Yangtse Portelles SENTINEL CH. SpA Via Robert Koch, 2 Milano, IT 20152 |
| Product Code | DFH |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-05 |
| Decision Date | 2009-09-03 |
| Summary: | summary |