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FDA 510(k)

MICROLET®NEXT Lancet

K-Number: K241810 · 2024-08-15

ApplicantAscensia Diabetes Care U.S., Inc.
Decision Date2024-08-15
Product CodeQRK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICROLET®NEXT 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 2024-08-15 under 510(k) number K241810. The device is classified under product code QRK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROLET®NEXT Lancet?

MICROLET®NEXT Lancet is a medical device that received FDA 510(k) clearance on 2024-08-15. The listed applicant is Ascensia Diabetes Care U.S., Inc.. The 510(k) number is K241810.

When did MICROLET®NEXT Lancet receive FDA 510(k) clearance?

MICROLET®NEXT Lancet received FDA 510(k) clearance on 2024-08-15, under 510(k) number K241810.

Who is the listed applicant for MICROLET®NEXT 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 Lancet?

The FDA product code for MICROLET®NEXT Lancet is QRK.

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 SystemK223293CONTOUR® NEXT GEN Blood Glucose Monitoring SystemK220633MICROLET NEXT lancing device, MICROLET LancetK162336Contour 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: QRK)

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.

K261634Disposable Blood Lancet (Soft)SteriLance Medical (Suzhou), Inc.K250016droplet® personal lancetsHtl-Strefa S.AK244031Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)SteriLance Medical (Suzhou), Inc.K242622Sterile Lancets for Single UseNingbo Caremed Medical Products Co., Ltd.K232330Lancing SystemNingbo Medsun Medical Co., Ltd.K230712SG Lanset I, SG Lancets, Soft LancetsSewon Medical Co.

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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