FDA 510(k)

FLEX 单克隆抗体小鼠抗人孕酮受体，克隆 PgR 1294，即用型（Dako Omnis）

K号: K170005 · 2017-12-21

决定日期2017-12-21

产品代码MXZ

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决定实质等同

器械摘要

FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) is the device name listed in this FDA 510(k) record. The listed applicant is Dako Denmark A/S. It received FDA 510(k) clearance on 2017-12-21 under 510(k) number K170005. 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 FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)?

FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) is a medical device that received FDA 510(k) clearance on 2017-12-21. The listed applicant is Dako Denmark A/S. The 510(k) number is K170005.

When did FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) receive FDA 510(k) clearance?

FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) received FDA 510(k) clearance on 2017-12-21, under 510(k) number K170005.

Who is the listed applicant for FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)?

The FDA 510(k) record lists Dako Denmark A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)?

The FDA product code for FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) is MXZ.

列明Dako Denmark A/S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。

K170028FLEX 单克隆抗体兔抗人雌激素受体α，克隆 EPI，即用型（Dako Onmis）

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.K183102BOND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Leica Biosystems Newcastle, Limited K171753BOND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, Limited K160922FLEX 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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