K203227 is an FDA 510(k) clearance for the Elecsys HCG STAT. This device is classified as a System, Test, Human Chorionic Gonadotropin (Class II - Special Controls, product code DHA).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on August 18, 2021, 289 days after receiving the submission on November 2, 2020.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1155.
| 510(k) Number | K203227 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 2020 |
| Decision Date | August 18, 2021 |
| Days to Decision | 289 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 |