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FDA PMA

PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS

Número do PMA: P000021 · 2025-05-22

RequerenteSiemens Healthcare Diagnostics
Data da decisão2025-05-22
Número PMAP000021
Código do produtoLTJ
Classe do DispositivoClasse 2
Especialidade MédicaI
Número da Regulamentação21 CFR 8
Comité consultivoIM

Resumo do dispositivo

PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS 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 2025-05-22. The device is classified under product code LTJ. It was reviewed by the IM advisory panel.

Perguntas frequentes

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 2025-05-22. The listed applicant is Siemens Healthcare Diagnostics.

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 Siemens Healthcare Diagnostics 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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