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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 a medical device manufactured by Ascensia Diabetes Care U.S., Inc.. It received FDA 510(k) clearance on 2022-06-03 under approval 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. It is manufactured by Ascensia Diabetes Care U.S., Inc.. The 510(k) number is K220633.

When was MICROLET NEXT lancing device, MICROLET Lancet approved by the FDA?

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

What company makes MICROLET NEXT lancing device, MICROLET Lancet?

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

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 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 K241787CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System K241810MICROLET®NEXT Lancet K250813MICROLET®NEXT 2 Lancing Device

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Related Devices (Code: QRL)

K222472Lancing System, Sterile Lancet for Single Use, Lancing DeviceShandong Lianfa Medical Plastic Products Co. , Ltd. K223099Facet Manatee Reusable Lancing BaseFacet Technologies, LLC K222656LDE4 Lancing DeviceI-Sens, Inc. K222246Disposable Sterile LancetTianjin Rilifine Medical Device Co., Ltd. K222539Facet Blood LancetsFacet Technologies, LLC K221072TRUEdraw Lancing Device, Mini Lancing DeviceTrividia Health

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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