K240403 is an FDA 510(k) clearance for the Access BR Monitor. This device is classified as a System, Test, Immunological, Antigen, Tumor (Class II - Special Controls, product code MOI).
Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on May 9, 2024, 90 days after receiving the submission on February 9, 2024.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K240403 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 2024 |
| Decision Date | May 09, 2024 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | MOI — System, Test, Immunological, Antigen, Tumor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6010 |