K231517 is an FDA 510(k) clearance for the VITROS Immunodiagnostic Products CEA Reagent Pack. This device is classified as a System, Test, Carcinoembryonic Antigen (Class II - Special Controls, product code DHX).
Submitted by Ortho-Clinical Diagnostics (Bridgend, GB). The FDA issued a Cleared decision on August 23, 2023, 90 days after receiving the submission on May 25, 2023.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K231517 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 25, 2023 |
| Decision Date | August 23, 2023 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DHX — System, Test, Carcinoembryonic Antigen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6010 |