FDA 510(k)

MAGLUMI 2000 FT4

K 號：K182423 · 2018-10-04

申請人Shenzhen New Industries Biomedical Engineering Co., Ltd.

決定日期2018-10-04

產品代碼CEC

諮詢委員會CH

決定相當於

器材摘要

MAGLUMI 2000 FT4 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen New Industries Biomedical Engineering Co., Ltd.. It received FDA 510(k) clearance on 2018-10-04 under 510(k) number K182423. The device is classified under product code CEC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MAGLUMI 2000 FT4?

MAGLUMI 2000 FT4 is a medical device that received FDA 510(k) clearance on 2018-10-04. The listed applicant is Shenzhen New Industries Biomedical Engineering Co., Ltd.. The 510(k) number is K182423.

When did MAGLUMI 2000 FT4 receive FDA 510(k) clearance?

MAGLUMI 2000 FT4 received FDA 510(k) clearance on 2018-10-04, under 510(k) number K182423.

Who is the listed applicant for MAGLUMI 2000 FT4?

The FDA 510(k) record lists Shenzhen New Industries Biomedical Engineering Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAGLUMI 2000 FT4?

The FDA product code for MAGLUMI 2000 FT4 is CEC.

其他以 Shenzhen New Industries Biomedical Engineering Co., 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。

K232587MAGLUMI 25-OH 膠質D，MAGLUMI X3 全自動化化學發光免疫分析儀 K192547MAGLUMI 2000 HCG/β-HCG K191499MAGLUMI 2000 25-OH 腫島鹼 K162698MAGLUMI 2000 TSH, MAGLUMI 2000 適用化分析儀

相關器械（代碼：CEC）

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。

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官方來源

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