K221990 is an FDA 510(k) clearance for the Access Total ßhCG (5th IS). This device is classified as a System, Test, Human Chorionic Gonadotropin (Class II - Special Controls, product code DHA).
Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on December 27, 2022, 174 days after receiving the submission on July 6, 2022.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K221990 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2022 |
| Decision Date | December 27, 2022 |
| Days to Decision | 174 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 |