FDA 510(k)

Полный набор анализатора C. difficile ARIES, Набор протоколов анализа C. difficile ARIES, Набор анализатора C. difficile ARIES (24 кассеты), Набор для ресуспендирования фекалий ARIES

Номер K: K171441 · 2017-07-21

Дата решения2017-07-21

Код продуктаOZN

Консультативный комитетMI

РешениеSubstantially Equivalent

Описание устройства

ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit is the device name listed in this FDA 510(k) record. The listed applicant is Luminex Corporation. It received FDA 510(k) clearance on 2017-07-21 under 510(k) number K171441. The device is classified under product code OZN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit?

ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit is a medical device that received FDA 510(k) clearance on 2017-07-21. The listed applicant is Luminex Corporation. The 510(k) number is K171441.

When did ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit receive FDA 510(k) clearance?

ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit received FDA 510(k) clearance on 2017-07-21, under 510(k) number K171441.

Who is the listed applicant for ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit?

The FDA 510(k) record lists Luminex Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit?

The FDA product code for ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit is OZN.

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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Другие записи, где Luminex Corporation указан как заявитель

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Связанные устройства (Код: OZN)

K260045cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190)Roche Molecular Systems, Inc.K243730Xpert C. difficile/EpiCepheid®K232092Great Basin Toxigenic C. difficile Direct Test (CDF2)Vela Operations USA K212427cobas Cdiff nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.K210385cobas Cdiff nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.K172569GenePOC CDiffGenepoc, Inc.

Официальный источник

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