K091741 is an FDA 510(k) clearance for the TINA-QUANT CERULOPLASMIN. This device is classified as a Immunochemical, Ceruloplasmin (Class II - Special Controls, product code CHN).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on March 18, 2010, 275 days after receiving the submission on June 16, 2009.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5210.
| 510(k) Number | K091741 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 2009 |
| Decision Date | March 18, 2010 |
| Days to Decision | 275 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 |