K113823 is an FDA 510(k) clearance for the HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT. This device is classified as a Method, Nephelometric, Immunoglobulins (g, A, M) (Class II - Special Controls, product code CFN).
Submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on March 27, 2013, 456 days after receiving the submission on December 27, 2011.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K113823 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2011 |
| Decision Date | March 27, 2013 |
| Days to Decision | 456 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | CFN — Method, Nephelometric, Immunoglobulins (g, A, M) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |