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FDA PMA

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

PMA 번호: P060005 · 2026-09-22

신청자Siemens Medical Solutions Diagnostics Limited
결정일2026-09-22
PMA 번호P060005
제품 코드MTG
의료기기 등급등급 3
의학적 전문분야U
자문 위원회IM

기기 요약

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.

자주 묻는 질문

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.

관련 임상시험

관련 기록은 이름, 제품 코드 또는 기타 메타데이터를 사용하여 자동으로 매칭됩니다. 매칭은 검증된 임상, 과학, 기업 또는 규제 상의 관계를 입증하지 않으며, 연결된 공식 출처를 검토하시기 바랍니다.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751의료 기기 인공지능 보조 유로-캠 캐터터 평가 시스템:膀胱癌 진단을 위한NOT_YET_RECRUITING

공식 출처

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