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FDA 510(k)

RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device

K-Number: K221062 · 2022-09-26

ApplicantBionime Corporation
Decision Date2022-09-26
Product CodeQRL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device is a medical device manufactured by Bionime Corporation. It received FDA 510(k) clearance on 2022-09-26 under approval number K221062. 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 RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device?

RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device is a medical device that received FDA 510(k) clearance on 2022-09-26. It is manufactured by Bionime Corporation. The 510(k) number is K221062.

When was RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device approved by the FDA?

RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device received FDA 510(k) clearance on 2022-09-26, under approval number K221062.

What company makes RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device?

RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device is manufactured by Bionime Corporation.

What is the FDA product code for RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device?

The FDA product code for RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device is QRL.

Other Devices by Bionime Corporation

K170143GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B, K161790iGlucose Blood Glucose Monitoring System K173638Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus K173139Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus K190564Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB K240637RIGHTEST Blood Glucose Monitoring System Max Tel

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Related Devices (Code: QRL)

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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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