FDA 510(k)

MAGLUMI 2000 25-OH Vitamin D

Número K: K191499 · 2019-08-01

RequerenteShenzhen New Industries Biomedical Engineering Co., Ltd.

Data da decisão2019-08-01

Código do produtoMRG

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

MAGLUMI 2000 25-OH Vitamin D 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 2019-08-01 under 510(k) number K191499. The device is classified under product code MRG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MAGLUMI 2000 25-OH Vitamin D?

MAGLUMI 2000 25-OH Vitamin D is a medical device that received FDA 510(k) clearance on 2019-08-01. The listed applicant is Shenzhen New Industries Biomedical Engineering Co., Ltd.. The 510(k) number is K191499.

When did MAGLUMI 2000 25-OH Vitamin D receive FDA 510(k) clearance?

MAGLUMI 2000 25-OH Vitamin D received FDA 510(k) clearance on 2019-08-01, under 510(k) number K191499.

Who is the listed applicant for MAGLUMI 2000 25-OH Vitamin D?

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 25-OH Vitamin D?

The FDA product code for MAGLUMI 2000 25-OH Vitamin D is MRG.

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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 K192547MAGLUMI 2000 HCG/ß-HCG K182423MAGLUMI 2000 FT4 K162698MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer

Dispositivos Relacionados (Código: MRG)

K232587MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzerShenzhen New Industries Biomedical Engineering Co., Ltd.K221817ALFIS Vitamina D, Analisador ALFIS-3Immunostics Inc.,K223503Access 25(OH) Vitamin D TotalBeckman Coulter, Inc.K210901Elecsys Vitamin D total IIIRoche Diagnostics K200509ADVIA Centaur Vitamin D Total (VitD)Siemens Healthcare Diagnostics, Inc.K180577BioPlex 2200 25-OH Vitamin D KitBio-Rad Laboratories

Fonte oficial

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