FDA 510(k)

MAGLUMI 2000 FT4

K号: K182423 · 2018-10-04

申请人Shenzhen New Industries Biomedical Engineering Co., Ltd.

决定日期2018-10-04

产品代码CEC

咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

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.

常见问题

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.

列明Shenzhen New Industries Biomedical Engineering Co., Ltd.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。

K232587MAGLUMI 25-OH 维生素D, MAGLUMI X3 全自动化学发光免疫分析仪 K192547MAGLUMI 2000 HCG/ß-HCG K191499MAGLUMI 2000 25-OH 维生素D K162698MAGLUMI 2000 TSH, MAGLUMI 2000 免疫分析仪

官方来源

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