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PMA de la FDA

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

Número de PMA: P000027 · 2026-04-29

SolicitanteRoche Diagnostics Corp.
Fecha de decisión2026-04-29
Número PMAP000027
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 Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2026-04-29. 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 2026-04-29. The listed applicant is Roche Diagnostics Corp..

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 Roche Diagnostics Corp. 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

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