K033811 is an FDA 510(k) clearance for the FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER. 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 January 30, 2004, 52 days after receiving the submission on December 9, 2003.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5550.
| 510(k) Number | K033811 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2003 |
| Decision Date | January 30, 2004 |
| Days to Decision | 52 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 |