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FDA 510(k)

BOND 即用型主要抗體 孕酮受體 (16)，Novocastra 液體小鼠單克隆抗體 孕酮受體克隆 16（濃縮液體抗體格式）。

K 號：K193393 · 2020-03-06

申請人Leica Biosystems Newcastle, Ltd.
決定日期2020-03-06
產品代碼MXZ
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

BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format). is the device name listed in this FDA 510(k) record. The listed applicant is Leica Biosystems Newcastle, Ltd.. It received FDA 510(k) clearance on 2020-03-06 under 510(k) number K193393. The device is classified under product code MXZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format).?

BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format). is a medical device that received FDA 510(k) clearance on 2020-03-06. The listed applicant is Leica Biosystems Newcastle, Ltd.. The 510(k) number is K193393.

When did BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format). receive FDA 510(k) clearance?

BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format). received FDA 510(k) clearance on 2020-03-06, under 510(k) number K193393.

Who is the listed applicant for BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format).?

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

What is the FDA product code for BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format).?

The FDA product code for BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format). is MXZ.

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, Ltd. 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。

K213348BOND MMR 抗體組合

相關器械（代碼：MXZ）

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Leica Biosystems Newcastle, LimitedK170005FLEX 鼠單克隆抗人黃體激素受體，克隆號 PgR 1294，即用型（Dako Omnis）Dako Denmark A/SK171753BOND 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 16Leica Biosystems Newcastle, LimitedK160922FLEX單克隆兔抗人雌激素受體a，克隆EP1，即用型（連結）；FLEX單克隆小鼠抗人孕酮受體，克隆PgR 636，即用型（連結）Dako North America, Inc.

官方來源

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