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# Beckman Coulter 510(k) Cleared for Clinical Analyzer
- URL: https://www.fdaweb.com/beckman-coulter-510-k-cleared-for-clinical-analyzer/
- Published: 2025-03-11T12:00:00.000Z
- Updated: 2026-09-14T14:54:57.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158803

FDA has cleared a Beckman Coulter Diagnostics 510(k) for its DxC 500i Clinical Analyzer. The integrated clinical chemistry and immunoassay analyzer is designed to enhance laboratory efficiency by offering high throughput and processing up to 800 clinical chemistry tests and 100 immunoassay tests per hour, according to the company.

One of the key features of the DxC 500i, according to the company, is its FlexMode operations, which prioritize testing based on sample urgency. The analyzer also includes a dynamic sample handler that automates repeat and re-run processes without operator intervention. Additionally, the device’s “intuitive user interface” supports new users with guided task indicators and step-by-step instructions, streamlining staff onboarding and training, it says.