测试，前列腺特异性抗原，游离的（非复合的），以区分前列腺癌和良性病变
PMA编号：P250026 · 2026-05-11
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决定日期2026-05-11
PMA 编号P250026
产品代码MTG
设备分类第3类
医疗专科U
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器械摘要
Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2026-05-11. The device is classified under product code MTG. It was reviewed by the IM advisory panel.
常见问题
What is the Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions?
Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions is a medical device that received FDA 510(k) clearance on 2026-05-11. The listed applicant is Siemens Healthcare Diagnostics, Inc..
When did Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions receive FDA 510(k) clearance?
The clearance date for Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions can be found in the official FDA records.
谁是Test，前列腺特异性抗原，游离（非复合）以区分前列腺癌和良性疾病的列名申请人？
FDA 510(k)记录中列出西门子医疗诊断公司（Siemens Healthcare Diagnostics, Inc.）为申请人。这本身并不足以确立该设备制造商的身份。
FDA产品代码是什么，用于区分前列腺特异性抗原（非复合型）测试，以区分前列腺癌和良性状况？
FDA产品代码为Test，前列腺特异性抗原，游离（非复合型），用于区分前列腺癌和良性病变，代码为MTG。
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官方来源
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