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FDA PMA

Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions

Número do PMA: P060005 · 2026-09-22

RequerenteSiemens Medical Solutions Diagnostics Limited
Data da decisão2026-09-22
Número PMAP060005
Código do produtoMTG
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoIM

Resumo do dispositivo

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.

Perguntas frequentes

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.

Who is the listed applicant for Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions?

The FDA 510(k) record lists Siemens Medical Solutions Diagnostics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions?

The FDA product code for Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions is MTG.

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