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FDA PMA

Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer

Número do PMA: P240021 · 2026-08-26

RequerenteSiemens Healthcare Diagnostics, Inc.
Data da decisão2026-08-26
Número PMAP240021
Código do produtoMTF
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoIM

Resumo do dispositivo

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 Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2026-08-26. The device is classified under product code MTF. It was reviewed by the IM advisory panel.

Perguntas frequentes

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 2026-08-26. The listed applicant is Siemens Healthcare Diagnostics, Inc..

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.

Who is the listed applicant for Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer?

The FDA 510(k) record lists Siemens Healthcare Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer?

The FDA product code for Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer is MTF.

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