FDA 510(k)

Blood Collection Accessory (BUCA)

Número K: K181754 · 2019-07-30

Data da decisão2019-07-30

Código do produtoJKA

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

Blood Collection Accessory (BUCA) is the device name listed in this FDA 510(k) record. The listed applicant is Nsp Tech Pte, Ltd.. It received FDA 510(k) clearance on 2019-07-30 under 510(k) number K181754. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Blood Collection Accessory (BUCA)?

Blood Collection Accessory (BUCA) is a medical device that received FDA 510(k) clearance on 2019-07-30. The listed applicant is Nsp Tech Pte, Ltd.. The 510(k) number is K181754.

When did Blood Collection Accessory (BUCA) receive FDA 510(k) clearance?

Blood Collection Accessory (BUCA) received FDA 510(k) clearance on 2019-07-30, under 510(k) number K181754.

Who is the listed applicant for Blood Collection Accessory (BUCA)?

The FDA 510(k) record lists Nsp Tech Pte, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Blood Collection Accessory (BUCA)?

The FDA product code for Blood Collection Accessory (BUCA) is JKA.

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Outros registros que listam Nsp Tech Pte, Ltd. como candidato(a)

K221783SafetiCET Safety Lancet K221604SafetiHeel, MediHeel, Novaplus K193074Bevel Up Holder K181743Blood Transfer Accessory (BTA)

Dispositivos Relacionados (Código: 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

Fonte oficial

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