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FDA 510(k)

OneTouch Delica Plus Lancing System

K-Number: K221546 · 2022-08-23

ApplicantAsahi Polyslider Co., Ltd.
Decision Date2022-08-23
Product CodeQRL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OneTouch Delica Plus Lancing System is a medical device manufactured by Asahi Polyslider Co., Ltd.. It received FDA 510(k) clearance on 2022-08-23 under approval number K221546. 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 OneTouch Delica Plus Lancing System?

OneTouch Delica Plus Lancing System is a medical device that received FDA 510(k) clearance on 2022-08-23. It is manufactured by Asahi Polyslider Co., Ltd.. The 510(k) number is K221546.

When was OneTouch Delica Plus Lancing System approved by the FDA?

OneTouch Delica Plus Lancing System received FDA 510(k) clearance on 2022-08-23, under approval number K221546.

What company makes OneTouch Delica Plus Lancing System?

OneTouch Delica Plus Lancing System is manufactured by Asahi Polyslider Co., Ltd..

What is the FDA product code for OneTouch Delica Plus Lancing System?

The FDA product code for OneTouch Delica Plus Lancing System is QRL.

Related Clinical Trials

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Other Devices by Asahi Polyslider Co., Ltd.

K222084OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie

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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