K031016 is an FDA 510(k) clearance for the FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II. This device is classified as a Lambda, Antigen, Antiserum, Control (Class II - Special Controls, product code DEH).
Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on July 15, 2003, 106 days after receiving the submission on March 31, 2003.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5550.
| 510(k) Number | K031016 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2003 |
| Decision Date | July 15, 2003 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DEH — Lambda, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5550 |