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FDA PMA

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

PMA番号：P060005 · 2026-09-22

申請者Siemens Medical Solutions Diagnostics Limited
決定日2026-09-22
PMA番号P060005
製品コードMTG
デバイスクラスクラス3
診療科U
諮問委員会IM

医療機器の概要

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.

よくある質問

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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