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FDA 510(k)

ONE DROP Lancing Device

K-Number: K223815 · 2023-02-15

ApplicantStat Medical Devices
Decision Date2023-02-15
Product CodeQRK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ONE DROP Lancing Device is the device name listed in this FDA 510(k) record. The listed applicant is Stat Medical Devices. It received FDA 510(k) clearance on 2023-02-15 under 510(k) number K223815. 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 ONE DROP Lancing Device?

ONE DROP Lancing Device is a medical device that received FDA 510(k) clearance on 2023-02-15. The listed applicant is Stat Medical Devices. The 510(k) number is K223815.

When did ONE DROP Lancing Device receive FDA 510(k) clearance?

ONE DROP Lancing Device received FDA 510(k) clearance on 2023-02-15, under 510(k) number K223815.

Who is the listed applicant for ONE DROP Lancing Device?

The FDA 510(k) record lists Stat Medical Devices as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ONE DROP Lancing Device?

The FDA product code for ONE DROP Lancing Device is QRK.

Other records listing Stat Medical Devices 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.

K230310STAT Medical Device Lancing SystemK222617EasyTouch Lancing Device

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.K241810MICROLET®NEXT LancetAscensia Diabetes Care U.S., Inc.K232330Lancing SystemNingbo Medsun Medical 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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