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FDA PMA

免疫組織化學試驗,抗體,黑色素瘤相關抗原A4

PMA 核准號:P230016 · 2026-09-21

決定日期2026-09-21
PMA 編號P230016
產品代碼SBL
器械分類3 類
醫療專科H
法規編號21 CFR 8
諮詢委員會PA

器材摘要

Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4 is the device name listed in this FDA 510(k) record. The listed applicant is Agilent Technologies, Inc.. It received FDA 510(k) clearance on 2026-09-21. The device is classified under product code SBL. It was reviewed by the PA advisory panel.

常見問題

What is the Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4?

Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4 is a medical device that received FDA 510(k) clearance on 2026-09-21. The listed applicant is Agilent Technologies, Inc..

When did Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4 receive FDA 510(k) clearance?

The clearance date for Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4 can be found in the official FDA records.

誰是免疫組織化學測試、抗體、黑色素瘤相關抗原A4的登記申請人?

The FDA 510(k) record lists Agilent Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

FDA產品代碼是什麼?免疫組織化學測試、抗體、黑色素瘤相關抗原A4?

FDA產品代碼為免疫組織化學測試、抗體、黑色素瘤相關抗原A4的是SBL。

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官方來源

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