K220176 is an FDA 510(k) clearance for the Elecsys AFP. This device is classified as a Kit, Test,alpha-fetoprotein For Testicular Cancer (Class II - Special Controls, product code LOJ).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on September 15, 2022, 237 days after receiving the submission on January 21, 2022.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K220176 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 2022 |
| Decision Date | September 15, 2022 |
| Days to Decision | 237 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | LOJ — Kit, Test,alpha-fetoprotein For Testicular Cancer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6010 |