K240987 is an FDA 510(k) clearance for the Access sTfR. This device is classified as a Transferrin, Antigen, Antiserum, Control (Class II - Special Controls, product code DDG).
Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on July 3, 2024, 84 days after receiving the submission on April 10, 2024.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5880.
| 510(k) Number | K240987 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 2024 |
| Decision Date | July 03, 2024 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DDG — Transferrin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5880 |