总计，前列腺特异性抗原（非复合型及复合型）用于检测前列腺癌
PMA编号：P170037 · 2019-01-30
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决定日期2019-01-30
PMA 编号P170037
产品代码MTF
设备分类第3类
医疗专科U
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器械摘要
Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer is the device name listed in this FDA 510(k) record. The listed applicant is Opko Diagnostics, LLC. It received FDA 510(k) clearance on 2019-01-30. The device is classified under product code MTF. It was reviewed by the IM advisory panel.
常见问题
What is the Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer?
Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer is a medical device that received FDA 510(k) clearance on 2019-01-30. The listed applicant is Opko Diagnostics, LLC.
When did Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer receive FDA 510(k) clearance?
The clearance date for Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer can be found in the official FDA records.
谁是Total前列腺特异性抗原（非复合物和复合物）用于检测前列腺癌的列名申请人？
The FDA 510(k) record lists Opko Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.
总前列腺特异性抗原（非复合型及复合型）检测前列腺癌的FDA产品代码是什么？
用于检测前列腺癌的Total前列腺特异性抗原（非复合物和复合物）的FDA产品代码是MTF。
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官方来源
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