면역조직학 검사, 항체, MET
PMA 번호: P240037 · 2025-07-11
광고
결정일2025-07-11
PMA 번호P240037
제품 코드SER
의료기기 등급등급 3
의학적 전문분야H
규정 번호21 CFR 8
자문 위원회PA
기기 요약
Immunohistochemistry Assay, Antibody, MET is the device name listed in this FDA 510(k) record. The listed applicant is Ventana Medical Systems, Inc. (Roche Tissue Diagnostics). It received FDA 510(k) clearance on 2025-07-11. The device is classified under product code SER. It was reviewed by the PA advisory panel.
자주 묻는 질문
What is the Immunohistochemistry Assay, Antibody, MET?
Immunohistochemistry Assay, Antibody, MET is a medical device that received FDA 510(k) clearance on 2025-07-11. The listed applicant is Ventana Medical Systems, Inc. (Roche Tissue Diagnostics).
When did Immunohistochemistry Assay, Antibody, MET receive FDA 510(k) clearance?
The clearance date for Immunohistochemistry Assay, Antibody, MET can be found in the official FDA records.
Who is the listed applicant for Immunohistochemistry Assay, Antibody, MET?
The FDA 510(k) record lists Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Immunohistochemistry Assay, Antibody, MET?
The FDA product code for Immunohistochemistry Assay, Antibody, MET is SER.
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.
공식 출처
FDA 데이터베이스에서 보기 →FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.
광고