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FDA 510(k)

Multi-Lancet Device 2, ReliOn Premier Lancing Device

K-Number: K221175 · 2022-10-17

ApplicantArkray, Inc.
Decision Date2022-10-17
Product CodeQRL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Multi-Lancet Device 2, ReliOn Premier Lancing Device is the device name listed in this FDA 510(k) record. The listed applicant is Arkray, Inc.. It received FDA 510(k) clearance on 2022-10-17 under 510(k) number K221175. 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 Multi-Lancet Device 2, ReliOn Premier Lancing Device?

Multi-Lancet Device 2, ReliOn Premier Lancing Device is a medical device that received FDA 510(k) clearance on 2022-10-17. The listed applicant is Arkray, Inc.. The 510(k) number is K221175.

When did Multi-Lancet Device 2, ReliOn Premier Lancing Device receive FDA 510(k) clearance?

Multi-Lancet Device 2, ReliOn Premier Lancing Device received FDA 510(k) clearance on 2022-10-17, under 510(k) number K221175.

Who is the listed applicant for Multi-Lancet Device 2, ReliOn Premier Lancing Device?

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

What is the FDA product code for Multi-Lancet Device 2, ReliOn Premier Lancing Device?

The FDA product code for Multi-Lancet Device 2, ReliOn Premier Lancing Device is QRL.

Other records listing Arkray, Inc. as applicant

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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

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