K140396 is an FDA 510(k) clearance for the FREELITE HUMAN LAMBDA FREE KIT. This device is classified as a Lambda, Antigen, Antiserum, Control (Class II - Special Controls, product code DEH).
Submitted by The Binding Site Group , Ltd. (San Diego, US). The FDA issued a Cleared decision on April 16, 2014, 57 days after receiving the submission on February 18, 2014.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5550.
| 510(k) Number | K140396 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 2014 |
| Decision Date | April 16, 2014 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DEH — Lambda, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5550 |