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FDA 510(k)

Disposable Blood Lancet

K-Number: K221507 · 2022-08-31

ApplicantSteriLance Medical (Suzhou), Inc.
Decision Date2022-08-31
Product CodeQRK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Blood Lancet is a medical device manufactured by SteriLance Medical (Suzhou), Inc.. It received FDA 510(k) clearance on 2022-08-31 under approval number K221507. 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 Disposable Blood Lancet?

Disposable Blood Lancet is a medical device that received FDA 510(k) clearance on 2022-08-31. It is manufactured by SteriLance Medical (Suzhou), Inc.. The 510(k) number is K221507.

When was Disposable Blood Lancet approved by the FDA?

Disposable Blood Lancet received FDA 510(k) clearance on 2022-08-31, under approval number K221507.

What company makes Disposable Blood Lancet?

Disposable Blood Lancet is manufactured by SteriLance Medical (Suzhou), Inc..

What is the FDA product code for Disposable Blood Lancet?

The FDA product code for Disposable Blood Lancet is QRK.

Related Clinical Trials

NCT07273877 "Real-world Assessment of BP Control in Patients With Hypertension by the Netrod RDN System" - REACH-RDN ENROLLING_BY_INVITATION

Other Devices by SteriLance Medical (Suzhou), Inc.

K153706Insulin Pen Needle K210745Heel Incision Safety Lancet K221521Disposable Safety Lancet K221970Lancing device K233796Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro) K244031Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)

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Related Devices (Code: QRK)

K221383MedtFine Blood LancetShanghai Carelife International Trading Co. , Ltd. 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. K222617EasyTouch Lancing DeviceStat Medical Devices

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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