FDA 510(k)

BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit

Номер K: K201017 · 2021-10-18

ЗаявительGeneohm Sciences Canada, Inc. (Bd Life Sciences)

Дата решения2021-10-18

Код продуктаPQA

Консультативный комитетMI

РешениеSubstantially Equivalent

Описание устройства

BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit is the device name listed in this FDA 510(k) record. The listed applicant is Geneohm Sciences Canada, Inc. (Bd Life Sciences). It received FDA 510(k) clearance on 2021-10-18 under 510(k) number K201017. The device is classified under product code PQA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit?

BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit is a medical device that received FDA 510(k) clearance on 2021-10-18. The listed applicant is Geneohm Sciences Canada, Inc. (Bd Life Sciences). The 510(k) number is K201017.

When did BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit receive FDA 510(k) clearance?

BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit received FDA 510(k) clearance on 2021-10-18, under 510(k) number K201017.

Who is the listed applicant for BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit?

The FDA 510(k) record lists Geneohm Sciences Canada, Inc. (Bd Life Sciences) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit?

The FDA product code for BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit is PQA.

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: PQA)

K260021cobas® BV/CVRoche Molecular Systems, Inc.K243725BD Vaginal PanelBecton, Dickinson and Company K243345Aptima BV Assay; Aptima CV/TV AssayHologic, Inc.K231381Xpert Xpress MVP; GeneXpert Xpress SystemCepheid K223653BD Vaginal PanelBecton, Dickinson and Company K221160Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemCepheid

Официальный источник

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