FDA 510(k)

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

K 號：K170028 · 2017-12-21

決定日期2017-12-21

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

FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) 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 K170028. 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 FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)?

FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) 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 K170028.

When did FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) receive FDA 510(k) clearance?

FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) received FDA 510(k) clearance on 2017-12-21, under 510(k) number K170028.

Who is the listed applicant for FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)?

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 Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)?

The FDA product code for FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) is MYA.

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。

K170005FLEX 鼠單克隆抗人黃體激素受體，克隆號 PgR 1294，即用型（Dako Omnis）

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。

K183100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，NovocastraLeica Biosystems Newcastle, Limited

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。