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FDA 510(k)

MICROLET NEXT lancing device, MICROLET Lancet

K-Number: K220633 · 2022-06-03

ApplicantAscensia Diabetes Care U.S., Inc.
Decision Date2022-06-03
Product CodeQRL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICROLET NEXT lancing device, MICROLET Lancet is the device name listed in this FDA 510(k) record. The listed applicant is Ascensia Diabetes Care U.S., Inc.. It received FDA 510(k) clearance on 2022-06-03 under 510(k) number K220633. 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 MICROLET NEXT lancing device, MICROLET Lancet?

MICROLET NEXT lancing device, MICROLET Lancet is a medical device that received FDA 510(k) clearance on 2022-06-03. The listed applicant is Ascensia Diabetes Care U.S., Inc.. The 510(k) number is K220633.

When did MICROLET NEXT lancing device, MICROLET Lancet receive FDA 510(k) clearance?

MICROLET NEXT lancing device, MICROLET Lancet received FDA 510(k) clearance on 2022-06-03, under 510(k) number K220633.

Who is the listed applicant for MICROLET NEXT lancing device, MICROLET Lancet?

The FDA 510(k) record lists Ascensia Diabetes Care U.S., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROLET NEXT lancing device, MICROLET Lancet?

The FDA product code for MICROLET NEXT lancing device, MICROLET Lancet is QRL.

Other records listing Ascensia Diabetes Care U.S., 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.

K250813MICROLET®NEXT 2 Lancing DeviceK241787CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring SystemK241810MICROLET®NEXT LancetK223293CONTOUR® NEXT GEN Blood Glucose Monitoring SystemK162336Contour Next EZ Blood Glucose Monitoring SystemK160430Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next 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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