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PMA de la FDA

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

Número de PMA: P970038 · 2025-05-15

SolicitanteBeckman Coulter, Inc.
Fecha de decisión2025-05-15
Número PMAP970038
Código de productoMTG
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorIM

Resumen del 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 Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2025-05-15. The device is classified under product code MTG. It was reviewed by the IM advisory panel.

Preguntas frecuentes

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 2025-05-15. The listed applicant is Beckman Coulter, Inc..

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 Beckman Coulter, Inc. 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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Fuente oficial

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