具有算法分析的多分析测试系统，用于检测前列腺癌
PMA编号：P200048 · 2026-07-28
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决定日期2026-07-28
PMA 编号P200048
产品代码QRF
设备分类第3类
医疗专科U
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器械摘要
Multi-analyte test system with algorithmic analysis for detection of prostate cancer is the device name listed in this FDA 510(k) record. The listed applicant is Cleveland Diagnostics, Inc.. It received FDA 510(k) clearance on 2026-07-28. The device is classified under product code QRF. It was reviewed by the IM advisory panel.
常见问题
What is the Multi-analyte test system with algorithmic analysis for detection of prostate cancer?
Multi-analyte test system with algorithmic analysis for detection of prostate cancer is a medical device that received FDA 510(k) clearance on 2026-07-28. The listed applicant is Cleveland Diagnostics, Inc..
When did Multi-analyte test system with algorithmic analysis for detection of prostate cancer receive FDA 510(k) clearance?
The clearance date for Multi-analyte test system with algorithmic analysis for detection of prostate cancer can be found in the official FDA records.
谁是用于检测前列腺癌的多分析测试系统（具有算法分析）的列名申请人？
The FDA 510(k) record lists Cleveland Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.
什么是用于检测前列腺癌的多分析测试系统算法分析的FDA产品代码？
FDA产品代码为用于检测前列腺癌的多分析测试系统带算法分析的是QRF。
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官方来源
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