K122965 is an FDA 510(k) clearance for the HUMAN CAERULOPLASMIN KIT. This device is classified as a Ceruloplasmin, Antigen, Antiserum, Control (Class II - Special Controls, product code DDB).
Submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on June 3, 2013, 252 days after receiving the submission on September 24, 2012.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5210.
| 510(k) Number | K122965 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2012 |
| Decision Date | June 03, 2013 |
| Days to Decision | 252 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DDB — Ceruloplasmin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5210 |