FDA 510(k)

MICROLET NEXT lancing device, MICROLET Lancet

N.º K: K220633 · 2022-06-03

SolicitanteAscensia Diabetes Care U.S., Inc.

Fecha de decisión2022-06-03

Código de productoQRL

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

MICROLET NEXT lancing device, MICROLET Lancet is the device name listed in this FDA 510(k) record. The listed applicant is Ascensia Diabetes Care U.S., Inc.. It received FDA 510(k) clearance on 2022-06-03 under 510(k) number K220633. 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 MICROLET NEXT lancing device, MICROLET Lancet?

MICROLET NEXT lancing device, MICROLET Lancet is a medical device that received FDA 510(k) clearance on 2022-06-03. The listed applicant is Ascensia Diabetes Care U.S., Inc.. The 510(k) number is K220633.

When did MICROLET NEXT lancing device, MICROLET Lancet receive FDA 510(k) clearance?

MICROLET NEXT lancing device, MICROLET Lancet received FDA 510(k) clearance on 2022-06-03, under 510(k) number K220633.

Who is the listed applicant for MICROLET NEXT lancing device, MICROLET Lancet?

The FDA 510(k) record lists Ascensia Diabetes Care U.S., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROLET NEXT lancing device, MICROLET Lancet?

The FDA product code for MICROLET NEXT lancing device, MICROLET Lancet is QRL.

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Otros registros que enlistan a Ascensia Diabetes Care U.S., Inc. como solicitante

K250813MICROLET®NEXT 2 Lancing Device K241787CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System K241810MICROLET®NEXT Lancet K223293CONTOUR® NEXT GEN Blood Glucose Monitoring System K162336Contour Next EZ Blood Glucose Monitoring System K160430Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System

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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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