K231832 is an FDA 510(k) clearance for the Access Myoglobin. This device is classified as a Myoglobin, Antigen, Antiserum, Control (Class II - Special Controls, product code DDR).
Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on September 18, 2023, 88 days after receiving the submission on June 22, 2023.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.5680.
| 510(k) Number | K231832 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 2023 |
| Decision Date | September 18, 2023 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DDR — Myoglobin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5680 |