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FDA 510(k)

雌性激素受體克隆6F11即用型原體抗體，適用於Bond，雌性激素受體克隆6F11濃縮液體原體抗體，Novocastra

K 號：K183100 · 2018-12-07

申請人Leica Biosystems Newcastle, Limited
決定日期2018-12-07
產品代碼MYA
諮詢委員會HE 請提供完整的描述文本，以便我能夠進行翻譯。
決定相當於

器材摘要

Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra is the device name listed in this FDA 510(k) record. The listed applicant is Leica Biosystems Newcastle, Limited. It received FDA 510(k) clearance on 2018-12-07 under 510(k) number K183100. The device is classified under product code MYA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra?

Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra is a medical device that received FDA 510(k) clearance on 2018-12-07. The listed applicant is Leica Biosystems Newcastle, Limited. The 510(k) number is K183100.

When did Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra receive FDA 510(k) clearance?

Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra received FDA 510(k) clearance on 2018-12-07, under 510(k) number K183100.

Who is the listed applicant for Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra?

The FDA 510(k) record lists Leica Biosystems Newcastle, Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra?

The FDA product code for Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra is MYA.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Leica Biosystems Newcastle, Limited 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K183102BOND 即用型（RTU）主要抗體 孕酮受體（16），Novocastra濃縮液體小鼠單克隆抗體K171753BOND 即用型（RTU）主要抗體 孕酮受體（16），Novocastra 液體小鼠單克隆抗體 孕酮受體克隆 16

相關器械（代碼：MYA）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K170028FLEX 適應人雌激素受體α單克隆兔抗體，克隆EPI，即用型（Dako Onmis）Dako Denmark A/S

官方來源

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