K222881 is an FDA 510(k) clearance for the Access hsTnI. This device is classified as a Immunoassay Method, Troponin Subunit (Class II - Special Controls, product code MMI).
Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on December 18, 2023, 452 days after receiving the submission on September 22, 2022.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K222881 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 22, 2022 |
| Decision Date | December 18, 2023 |
| Days to Decision | 452 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | MMI — Immunoassay Method, Troponin Subunit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1215 |