FDA 510(k)

MAGLUMI 25-OH 维生素D, MAGLUMI X3 全自动化学发光免疫分析仪

K号: K232587 · 2024-04-12

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

决定日期2024-04-12

产品代码MRG

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 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer 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 2024-04-12 under 510(k) number K232587. The device is classified under product code MRG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer?

MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer is a medical device that received FDA 510(k) clearance on 2024-04-12. The listed applicant is Shenzhen New Industries Biomedical Engineering Co., Ltd.. The 510(k) number is K232587.

When did MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer receive FDA 510(k) clearance?

MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer received FDA 510(k) clearance on 2024-04-12, under 510(k) number K232587.

Who is the listed applicant for MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer?

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 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer?

The FDA product code for MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer is MRG.

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。

K192547MAGLUMI 2000 HCG/ß-HCG K191499MAGLUMI 2000 25-OH 维生素D K182423MAGLUMI 2000 FT4 K162698MAGLUMI 2000 TSH, MAGLUMI 2000 免疫分析仪

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