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FDA 510(k)

Accu-Chek FastClix Blood Lancing System

K-Number: K220608 · 2022-04-29

ApplicantRoche Diabetes Care, Inc.
Decision Date2022-04-29
Product CodeQRL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Roche Diabetes Care, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232509Accu-Chek Safe-T-Pro Uno Lancing DeviceK232488Accu-Chek Safe-T-Pro Plus Lancing DeviceK213134Accu-Chek Solo micropump system with interoperable technologyK213131Accu-Chek Guide Solo diabetes manager blood glucose monitoring systemK220849Accu-Chek Safe-T-Pro Plus Lancing DeviceK203711IWL2020 Blood Glucose Monitoring System

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Related Devices (Code: QRL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.K232912Facet Aurora Reusable Lancet BaseFacet Technologies, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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