K230648 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 4, 2023, 270 days after receiving the submission on March 9, 2023.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K230648 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 2023 |
| Decision Date | December 04, 2023 |
| Days to Decision | 270 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 |