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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 a medical device manufactured by Ascensia Diabetes Care U.S., Inc.. It received FDA 510(k) clearance on 2024-08-15 under approval 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. It is manufactured by Ascensia Diabetes Care U.S., Inc.. The 510(k) number is K241810.

When was MICROLET®NEXT Lancet approved by the FDA?

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

What company makes MICROLET®NEXT Lancet?

MICROLET®NEXT Lancet is manufactured by Ascensia Diabetes Care U.S., Inc..

What is the FDA product code for MICROLET®NEXT Lancet?

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

Other Devices by Ascensia Diabetes Care U.S., Inc.

K160430Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System K162336Contour Next EZ Blood Glucose Monitoring System K223293CONTOUR® NEXT GEN Blood Glucose Monitoring System K220633MICROLET NEXT lancing device, MICROLET Lancet K241787CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System K250813MICROLET®NEXT 2 Lancing Device

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Related Devices (Code: QRK)

K221383MedtFine Blood LancetShanghai Carelife International Trading Co. , Ltd. K221507Disposable Blood LancetSteriLance Medical (Suzhou), Inc. K221433Facet 28G Universal LancetFacet Technologies, LLC K230712SG Lanset I, SG Lancets, Soft LancetsSewon Medical Co. K230310STAT Medical Device Lancing SystemStat Medical Devices K230759SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro)Bosungmeditech Co., Ltd.

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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