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：P060005 · 2026-09-22
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决定日期2026-09-22
PMA 编号P060005
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 Medical Solutions Diagnostics Limited. It received FDA 510(k) clearance on 2026-09-22. 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 2026-09-22. The listed applicant is Siemens Medical Solutions Diagnostics Limited.
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？
The FDA 510(k) record lists Siemens Medical Solutions Diagnostics Limited as the applicant. This does not by itself establish the device manufacturer.
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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