Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Bionime Corporation. It received FDA 510(k) clearance on 2022-09-26 under 510(k) 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. The listed applicant is Bionime Corporation. The 510(k) number is K221062.

When did RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device receive FDA 510(k) clearance?

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

Who is the listed applicant for RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device?

The FDA 510(k) record lists Bionime Corporation as the applicant. This does not by itself establish the device manufacturer.

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 records listing Bionime Corporation 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.

K240637RIGHTEST Blood Glucose Monitoring System Max TelK231192RIGHTEST Blood Glucose Monitoring System Max TelK190564Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SBK173638Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max PlusK173139Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz PlusK170143GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B,

View all 8 devices →

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.

↑