FDA 510(k)

Monarch Blood Collection Set

Номер K: K232308 · 2023-12-04

Дата решения2023-12-04

Код продуктаJKA

Консультативный комитетCH

РешениеSubstantially Equivalent

Описание устройства

Monarch Blood Collection Set is the device name listed in this FDA 510(k) record. The listed applicant is The Monarch Company. It received FDA 510(k) clearance on 2023-12-04 under 510(k) number K232308. 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 Monarch Blood Collection Set?

Monarch Blood Collection Set is a medical device that received FDA 510(k) clearance on 2023-12-04. The listed applicant is The Monarch Company. The 510(k) number is K232308.

When did Monarch Blood Collection Set receive FDA 510(k) clearance?

Monarch Blood Collection Set received FDA 510(k) clearance on 2023-12-04, under 510(k) number K232308.

Who is the listed applicant for Monarch Blood Collection Set?

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

What is the FDA product code for Monarch Blood Collection Set?

The FDA product code for Monarch Blood Collection Set 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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