FDA 510(k)

FLEX 鼠單克隆抗人黃體激素受體，克隆號 PgR 1294，即用型（Dako Omnis）

K 號：K170005 · 2017-12-21

決定日期2017-12-21

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

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.

常見問題

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.

其他以 Dako Denmark A/S 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。

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

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。

K193393BOND 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）。Leica Biosystems Newcastle, Ltd.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, Limited 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 16Leica Biosystems Newcastle, Limited K160922FLEX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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