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PMA de la FDA

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

Número de PMA: P000021 · 2025-05-22

SolicitanteSiemens Healthcare Diagnostics
Fecha de decisión2025-05-22
Número PMAP000021
Código de productoLTJ
Clase del dispositivoClase 2
Especialidad médicaI
Número de regulación21 CFR 8
Comité asesorIM

Resumen del 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.

Preguntas frecuentes

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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Fuente oficial

Ver en la base de datos de la FDA →

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