FDA 510(k)

Multi-Lancet Device 2, ReliOn Premier Lancing Device

N.º K: K221175 · 2022-10-17

Fecha de decisión2022-10-17

Código de productoQRL

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Multi-Lancet Device 2, ReliOn Premier Lancing Device is the device name listed in this FDA 510(k) record. The listed applicant is Arkray, Inc.. It received FDA 510(k) clearance on 2022-10-17 under 510(k) number K221175. The device is classified under product code QRL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Multi-Lancet Device 2, ReliOn Premier Lancing Device?

Multi-Lancet Device 2, ReliOn Premier Lancing Device is a medical device that received FDA 510(k) clearance on 2022-10-17. The listed applicant is Arkray, Inc.. The 510(k) number is K221175.

When did Multi-Lancet Device 2, ReliOn Premier Lancing Device receive FDA 510(k) clearance?

Multi-Lancet Device 2, ReliOn Premier Lancing Device received FDA 510(k) clearance on 2022-10-17, under 510(k) number K221175.

Who is the listed applicant for Multi-Lancet Device 2, ReliOn Premier Lancing Device?

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

What is the FDA product code for Multi-Lancet Device 2, ReliOn Premier Lancing Device?

The FDA product code for Multi-Lancet Device 2, ReliOn Premier Lancing Device is QRL.

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Otros registros que enlistan a Arkray, Inc. como solicitante

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Dispositivos relacionados (Código: QRL)

K262135Lancing deviceTianjin Huahong Technology Co., Ltd.K262211LancetTianjin Huahong Technology Co., Ltd.K260122Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)SteriLance Medical (Suzhou), Inc.K253706Lancing device (HH-XV-T)Tianjin Huahong Technology Co., Ltd.K250813MICROLET®NEXT 2 Lancing DeviceAscensia Diabetes Care U.S., Inc.K243306Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T)Tianjin Huahong Technology Co., Ltd.

Fuente oficial

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