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FDA 510(k)

Accu-Chek Softclix Blood Lancing System

K-Number: K214022 · 2022-02-17

ApplicantRoche Diabetes Care, Inc.
Decision Date2022-02-17
Product CodeQRL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Accu-Chek Softclix Blood Lancing System is a medical device manufactured by Roche Diabetes Care, Inc.. It received FDA 510(k) clearance on 2022-02-17 under approval number K214022. 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 Softclix Blood Lancing System?

Accu-Chek Softclix Blood Lancing System is a medical device that received FDA 510(k) clearance on 2022-02-17. It is manufactured by Roche Diabetes Care, Inc.. The 510(k) number is K214022.

When was Accu-Chek Softclix Blood Lancing System approved by the FDA?

Accu-Chek Softclix Blood Lancing System received FDA 510(k) clearance on 2022-02-17, under approval number K214022.

What company makes Accu-Chek Softclix Blood Lancing System?

Accu-Chek Softclix Blood Lancing System is manufactured by Roche Diabetes Care, Inc..

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

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

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Related PubMed Literature

PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

Other Devices by Roche Diabetes Care, Inc.

K160944ACCU-CHEK Guide Blood Glucose Monitoring System K220849Accu-Chek Safe-T-Pro Plus Lancing Device K203711IWL2020 Blood Glucose Monitoring System K220608Accu-Chek FastClix Blood Lancing System K220364Accu-Chek Safe-T-Pro Uno Lancing Device K232488Accu-Chek Safe-T-Pro Plus Lancing Device

View all 8 devices →

Related Devices (Code: QRL)

K222472Lancing System, Sterile Lancet for Single Use, Lancing DeviceShandong Lianfa Medical Plastic Products Co. , Ltd. K223099Facet Manatee Reusable Lancing BaseFacet Technologies, LLC K222656LDE4 Lancing DeviceI-Sens, Inc. K222246Disposable Sterile LancetTianjin Rilifine Medical Device Co., Ltd. K222539Facet Blood LancetsFacet Technologies, LLC K221072TRUEdraw Lancing Device, Mini Lancing DeviceTrividia Health

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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