K234052 is an FDA 510(k) clearance for the Access Ferritin. This device is classified as a Radioimmunoassay (two-site Solid Phase), Ferritin (Class II - Special Controls, product code JMG).
Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on March 20, 2024, 90 days after receiving the submission on December 21, 2023.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5340.
| 510(k) Number | K234052 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2023 |
| Decision Date | March 20, 2024 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | JMG — Radioimmunoassay (two-site Solid Phase), Ferritin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5340 |