K213626 is an FDA 510(k) clearance for the VITROS AFP. This device is classified as a Kit, Test,alpha-fetoprotein For Testicular Cancer (Class II - Special Controls, product code LOJ).
Submitted by Ortho-Clinical Diagnostics (Pencoed, GB). The FDA issued a Cleared decision on June 15, 2022, 210 days after receiving the submission on November 17, 2021.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K213626 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2021 |
| Decision Date | June 15, 2022 |
| Days to Decision | 210 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 |