FDA 510(k)

MBT Compass HT CA Software; MBT FAST Shuttle US IVD

Номер K: K251495 · 2025-08-13

Дата решения2025-08-13

Код продуктаQBN

Консультативный комитетMI

РешениеSubstantially Equivalent

Описание устройства

MBT Compass HT CA Software; MBT FAST Shuttle US IVD is the device name listed in this FDA 510(k) record. The listed applicant is Bruker Daltonics GmbH & Co. KG. It received FDA 510(k) clearance on 2025-08-13 under 510(k) number K251495. The device is classified under product code QBN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the MBT Compass HT CA Software; MBT FAST Shuttle US IVD?

MBT Compass HT CA Software; MBT FAST Shuttle US IVD is a medical device that received FDA 510(k) clearance on 2025-08-13. The listed applicant is Bruker Daltonics GmbH & Co. KG. The 510(k) number is K251495.

When did MBT Compass HT CA Software; MBT FAST Shuttle US IVD receive FDA 510(k) clearance?

MBT Compass HT CA Software; MBT FAST Shuttle US IVD received FDA 510(k) clearance on 2025-08-13, under 510(k) number K251495.

Who is the listed applicant for MBT Compass HT CA Software; MBT FAST Shuttle US IVD?

The FDA 510(k) record lists Bruker Daltonics GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MBT Compass HT CA Software; MBT FAST Shuttle US IVD?

The FDA product code for MBT Compass HT CA Software; MBT FAST Shuttle US IVD is QBN.

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: QBN)

K212461VITEK MS PRIMEbioMerieux, Inc.K181412VITEK MSbioMerieux, Inc.

Официальный источник

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