K062114 is an FDA 510(k) clearance for the CERULOPLASMIN, MODEL 2055953. This device is classified as a Immunochemical, Ceruloplasmin (Class II - Special Controls, product code CHN).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on January 31, 2007, 191 days after receiving the submission on July 24, 2006.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5210.
| 510(k) Number | K062114 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 2006 |
| Decision Date | January 31, 2007 |
| Days to Decision | 191 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | CHN — Immunochemical, Ceruloplasmin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5210 |