FDA 510(k)

MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer

Número K: K162698 · 2017-07-14

RequerenteShenzhen New Industries Biomedical Engineering Co., Ltd.

Data da decisão2017-07-14

Código do produtoJLW

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

MAGLUMI 2000 TSH, MAGLUMI 2000 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 2017-07-14 under 510(k) number K162698. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer?

MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer is a medical device that received FDA 510(k) clearance on 2017-07-14. The listed applicant is Shenzhen New Industries Biomedical Engineering Co., Ltd.. The 510(k) number is K162698.

When did MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer receive FDA 510(k) clearance?

MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer received FDA 510(k) clearance on 2017-07-14, under 510(k) number K162698.

Who is the listed applicant for MAGLUMI 2000 TSH, MAGLUMI 2000 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 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer?

The FDA product code for MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer is JLW.

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