FDA 510(k)

LifeOutcomes C-Quest™ Blood Culture Sampling Device

Номер K: K231282 · 2024-01-26

Дата решения2024-01-26

Код продуктаJKA

Консультативный комитетCH

РешениеSubstantially Equivalent

Описание устройства

LifeOutcomes C-Quest™ Blood Culture Sampling Device is the device name listed in this FDA 510(k) record. The listed applicant is Lifeoutcomes, LLC. It received FDA 510(k) clearance on 2024-01-26 under 510(k) number K231282. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the LifeOutcomes C-Quest™ Blood Culture Sampling Device?

LifeOutcomes C-Quest™ Blood Culture Sampling Device is a medical device that received FDA 510(k) clearance on 2024-01-26. The listed applicant is Lifeoutcomes, LLC. The 510(k) number is K231282.

When did LifeOutcomes C-Quest™ Blood Culture Sampling Device receive FDA 510(k) clearance?

LifeOutcomes C-Quest™ Blood Culture Sampling Device received FDA 510(k) clearance on 2024-01-26, under 510(k) number K231282.

Who is the listed applicant for LifeOutcomes C-Quest™ Blood Culture Sampling Device?

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

What is the FDA product code for LifeOutcomes C-Quest™ Blood Culture Sampling Device?

The FDA product code for LifeOutcomes C-Quest™ Blood Culture Sampling Device is JKA.

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: JKA)

K262215Profoject™ Safety Sliding Blood Collection SetCMT Health PTE., Ltd.K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd.K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and Company K252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and Company K252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderBecton, Dickinson and Company K252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection TubesBecton, Dickinson and Company

Официальный источник

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