K120056 is an FDA 510(k) clearance for the HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER. This device is classified as a Kappa, Antigen, Antiserum, Control (Class II - Special Controls, product code DFH).
Submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on April 1, 2013, 448 days after receiving the submission on January 9, 2012.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5550.
| 510(k) Number | K120056 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 2012 |
| Decision Date | April 01, 2013 |
| Days to Decision | 448 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 |