FDA 510(k)

Sistema de punção de sangue Accu-Chek FastClix

Número K: K220608 · 2022-04-29

Data da decisão2022-04-29

Código do produtoQRL

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Accu-Chek FastClix Blood Lancing System is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diabetes Care, Inc.. It received FDA 510(k) clearance on 2022-04-29 under 510(k) number K220608. The device is classified under product code QRL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Accu-Chek FastClix Blood Lancing System?

Accu-Chek FastClix Blood Lancing System is a medical device that received FDA 510(k) clearance on 2022-04-29. The listed applicant is Roche Diabetes Care, Inc.. The 510(k) number is K220608.

When did Accu-Chek FastClix Blood Lancing System receive FDA 510(k) clearance?

Accu-Chek FastClix Blood Lancing System received FDA 510(k) clearance on 2022-04-29, under 510(k) number K220608.

Who is the listed applicant for Accu-Chek FastClix Blood Lancing System?

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

What is the FDA product code for Accu-Chek FastClix Blood Lancing System?

The FDA product code for Accu-Chek FastClix Blood Lancing System is QRL.

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Outros registros que listam Roche Diabetes Care, Inc. como candidato(a)

K232509Dispositivo de Lanceta Accu-Chek Safe-T-Pro Uno K232488Dispositivo de Lanceta Accu-Chek Safe-T-Pro Plus K220849Dispositivo de Lanceta Accu-Chek Safe-T-Pro Plus K203711IWL2020 Blood Glucose Monitoring System K220364Dispositivo de Lanceta Accu-Chek Safe-T-Pro Uno K214022Sistema de Lanceta de Sangue Accu-Chek Softclix

Ver todos os 8 dispositivos →

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.

Fonte oficial

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