FDA 510(k)

DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12

Номер K: K190298 · 2019-10-04

ЗаявительBeckman Coulter Biomedical GmbH

Дата решения2019-10-04

Код продуктаCDD

Консультативный комитетCH

РешениеSubstantially Equivalent

Описание устройства

DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter Biomedical GmbH. It received FDA 510(k) clearance on 2019-10-04 under 510(k) number K190298. The device is classified under product code CDD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12?

DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 is a medical device that received FDA 510(k) clearance on 2019-10-04. The listed applicant is Beckman Coulter Biomedical GmbH. The 510(k) number is K190298.

When did DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 receive FDA 510(k) clearance?

DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 received FDA 510(k) clearance on 2019-10-04, under 510(k) number K190298.

Who is the listed applicant for DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12?

The FDA 510(k) record lists Beckman Coulter Biomedical GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12?

The FDA product code for DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 is CDD.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: CDD)

K233541ARCHITECT Active-B12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd.K223289Access Vitamin B12Beckman Coulter, Inc.K192064LIAISON Vitamin B12DiaSorin, Inc.K172133ADVIA Centaur Active-B12 (Холотрансcobalamin) (AB12) ОпределениеAxis-Shield Diagnostics, Ltd.K161721Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls SetDiazyme Laboratories K160757ADVIA Centaur Active-B12 (Холотранскоальбамин)(AB12) Анализ, Контроль качества ADVIA Centaur Active-B12(AB12) и Материалы контрольной кривой Master Curve (MCM) ADVIA Centaur Active-B12 (AB12)Axis-Shield Diagnostics Limited

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