K083602 is an FDA 510(k) clearance for the KAPPA LIGHT CHAINS. This device is classified as a Kappa, Antigen, Antiserum, Control (Class II - Special Controls, product code DFH).
Submitted by SENTINEL CH. SpA (Milan, IT). The FDA issued a Cleared decision on September 3, 2009, 272 days after receiving the submission on December 5, 2008.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5550.
| 510(k) Number | K083602 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 2008 |
| Decision Date | September 03, 2009 |
| Days to Decision | 272 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DFH - Kappa, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5550 |