FDA 510(k)

MAGLUMI 2000 HCG/ß-HCG

Número K: K192547 · 2020-01-17

RequerenteShenzhen New Industries Biomedical Engineering Co., Ltd.

Data da decisão2020-01-17

Código do produtoDHA

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

MAGLUMI 2000 HCG/ß-HCG 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 2020-01-17 under 510(k) number K192547. The device is classified under product code DHA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MAGLUMI 2000 HCG/ß-HCG?

MAGLUMI 2000 HCG/ß-HCG is a medical device that received FDA 510(k) clearance on 2020-01-17. The listed applicant is Shenzhen New Industries Biomedical Engineering Co., Ltd.. The 510(k) number is K192547.

When did MAGLUMI 2000 HCG/ß-HCG receive FDA 510(k) clearance?

MAGLUMI 2000 HCG/ß-HCG received FDA 510(k) clearance on 2020-01-17, under 510(k) number K192547.

Who is the listed applicant for MAGLUMI 2000 HCG/ß-HCG?

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 HCG/ß-HCG?

The FDA product code for MAGLUMI 2000 HCG/ß-HCG is DHA.

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Outros registros que listam Shenzhen New Industries Biomedical Engineering Co., Ltd. como candidato(a)

K232587MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer K191499MAGLUMI 2000 25-OH Vitamin D K182423MAGLUMI 2000 FT4 K162698MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer

Dispositivos Relacionados (Código: DHA)

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Fonte oficial

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