前列腺特异性抗原（PSA）用于前列腺癌的管理
PMA编号：P000027 · 2026-04-29
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决定日期2026-04-29
PMA 编号P000027
产品代码LTJ
设备分类第2类
医疗专科I
法规编号21 CFR 8
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器械摘要
PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2026-04-29. The device is classified under product code LTJ. It was reviewed by the IM advisory panel.
常见问题
What is the PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS?
PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS is a medical device that received FDA 510(k) clearance on 2026-04-29. The listed applicant is Roche Diagnostics Corp..
When did PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS receive FDA 510(k) clearance?
The clearance date for PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS can be found in the official FDA records.
Who is the listed applicant for PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS?
The FDA 510(k) record lists Roche Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS?
The FDA product code for PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS is LTJ.
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官方来源
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