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FDA 510(k)

BOND即用型（RTU）孕酮受体（16）主要抗体，Novocastra浓缩液体小鼠单克隆抗体

K号: K183102 · 2018-12-07

申请人Leica Biosystems Newcastle, Limited
决定日期2018-12-07
产品代码MXZ
咨询委员会HE 请注意，由于您只提供了“HE”作为输入，我无法提供完整的翻译。请提供完整的描述或文本，以便我能够进行准确的翻译。
决定实质等同

器械摘要

BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody 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 K183102. The device is classified under product code MXZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

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

BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody 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 K183102.

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

BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody received FDA 510(k) clearance on 2018-12-07, under 510(k) number K183102.

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

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 BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody?

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

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Leica Biosystems Newcastle, Limited为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K183100Estrogen 受体克隆 6F11 即用型初级抗体，用于 Bond，Estrogen 受体克隆 6F11 液体浓缩初级抗体，NovocastraK171753BOND即用型（RTU）孕酮受体（16）主要抗体，Novocastra液体小鼠单克隆抗体孕酮受体克隆16

相关器械（代码：MXZ）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K193393BOND即用型主要抗体孕酮受体（16），Novocastra液体小鼠单克隆抗体孕酮受体克隆16（浓缩液体抗体格式）Leica Biosystems Newcastle, Ltd.K170005FLEX 单克隆抗体小鼠抗人孕酮受体，克隆 PgR 1294，即用型（Dako Omnis）Dako Denmark A/SK171753BOND即用型（RTU）孕酮受体（16）主要抗体，Novocastra液体小鼠单克隆抗体孕酮受体克隆16Leica Biosystems Newcastle, LimitedK160922FLEX 单克隆抗体兔抗人雌激素受体α，克隆 EP1，即用型（Link）；FLEX 单克隆抗体小鼠抗人孕酮受体，克隆 PgR 636，即用型（Link）Dako North America, Inc.

官方来源

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