FDA 510(k)

Lancing System, Sterile Lancet for Single Use, Lancing Device

N.º K: K222472 · 2022-11-30

SolicitanteShandong Lianfa Medical Plastic Products Co. , Ltd.

Fecha de decisión2022-11-30

Código de productoQRL

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Lancing System, Sterile Lancet for Single Use, Lancing Device is the device name listed in this FDA 510(k) record. The listed applicant is Shandong Lianfa Medical Plastic Products Co. , Ltd.. It received FDA 510(k) clearance on 2022-11-30 under 510(k) number K222472. 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 Lancing System, Sterile Lancet for Single Use, Lancing Device?

Lancing System, Sterile Lancet for Single Use, Lancing Device is a medical device that received FDA 510(k) clearance on 2022-11-30. The listed applicant is Shandong Lianfa Medical Plastic Products Co. , Ltd.. The 510(k) number is K222472.

When did Lancing System, Sterile Lancet for Single Use, Lancing Device receive FDA 510(k) clearance?

Lancing System, Sterile Lancet for Single Use, Lancing Device received FDA 510(k) clearance on 2022-11-30, under 510(k) number K222472.

Who is the listed applicant for Lancing System, Sterile Lancet for Single Use, Lancing Device?

The FDA 510(k) record lists Shandong Lianfa Medical Plastic Products Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lancing System, Sterile Lancet for Single Use, Lancing Device?

The FDA product code for Lancing System, Sterile Lancet for Single Use, Lancing Device is QRL.

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Otros registros que enlistan a Shandong Lianfa Medical Plastic Products Co. , Ltd. como solicitante

K222376Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)

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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