K182095 is an FDA 510(k) clearance for the Tina-quant Transferrin ver.2 (urine application). This device is classified as a Transferrin, Antigen, Antiserum, Control (Class II - Special Controls, product code DDG).
Submitted by Roche Diagnostics Operations (Rdo) (Indianapolis, US). The FDA issued a Cleared decision on November 5, 2018, 94 days after receiving the submission on August 3, 2018.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5880.
| 510(k) Number | K182095 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 2018 |
| Decision Date | November 05, 2018 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DDG — Transferrin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5880 |