K233581 is an FDA 510(k) clearance for the VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack. This device is classified as a System, Test, Human Chorionic Gonadotropin (Class II - Special Controls, product code DHA).
Submitted by Ortho-Clinical Diagnostics (Bridgend, GB). The FDA issued a Cleared decision on May 8, 2024, 183 days after receiving the submission on November 7, 2023.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K233581 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 2023 |
| Decision Date | May 08, 2024 |
| Days to Decision | 183 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DHA — System, Test, Human Chorionic Gonadotropin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1155 |