ANTIGEN(复合物), 前列腺特异性(PSA)
PMA编号：P990055 · 2025-07-16
广告
决定日期2025-07-16
PMA 编号P990055
产品代码NAF
设备分类第3类
医疗专科U
咨询委员会抱歉，您提供的信息不完整，无法进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
器械摘要
ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2025-07-16. The device is classified under product code NAF. It was reviewed by the IM advisory panel.
常见问题
What is the ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)?
ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA) is a medical device that received FDA 510(k) clearance on 2025-07-16. The listed applicant is Siemens Healthcare Diagnostics.
When did ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA) receive FDA 510(k) clearance?
The clearance date for ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA) can be found in the official FDA records.
Who is the listed applicant for ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)?
The FDA 510(k) record lists Siemens Healthcare Diagnostics as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA)?
The FDA product code for ANTIGEN(COMPLEXED),PROSTATE SPECIFIC,(CPSA) is NAF.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
广告