K241220 is an FDA 510(k) clearance for the Tina-quant Lipoprotein(a) Gen.2 Molarity. This device is classified as a Lipoprotein, Low-density, Antigen, Antiserum, Control (Class II - Special Controls, product code DFC).
Submitted by Roche Diagnostics Operations (Indianapolis, US). The FDA issued a Cleared decision on January 24, 2025, 268 days after receiving the submission on May 1, 2024.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5600.
| 510(k) Number | K241220 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2024 |
| Decision Date | January 24, 2025 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DFC — Lipoprotein, Low-density, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5600 |