K230937 is an FDA 510(k) clearance for the Alinity i Total ß-hCG Reagent Kit, GLP systems Track. This device is classified as a System, Test, Human Chorionic Gonadotropin (Class II - Special Controls, product code DHA).
Submitted by Abbott Laboratories (Iriving, US). The FDA issued a Cleared decision on June 5, 2023, 63 days after receiving the submission on April 3, 2023.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K230937 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 2023 |
| Decision Date | June 05, 2023 |
| Days to Decision | 63 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 |