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FDA 510(k)

Sterile Lancets for Single Use

K-Number: K242622 · 2024-10-28

ApplicantNingbo Caremed Medical Products Co., Ltd.
Decision Date2024-10-28
Product CodeQRK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sterile Lancets for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Caremed Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2024-10-28 under 510(k) number K242622. 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 Sterile Lancets for Single Use?

Sterile Lancets for Single Use is a medical device that received FDA 510(k) clearance on 2024-10-28. The listed applicant is Ningbo Caremed Medical Products Co., Ltd.. The 510(k) number is K242622.

When did Sterile Lancets for Single Use receive FDA 510(k) clearance?

Sterile Lancets for Single Use received FDA 510(k) clearance on 2024-10-28, under 510(k) number K242622.

Who is the listed applicant for Sterile Lancets for Single Use?

The FDA 510(k) record lists Ningbo Caremed Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Lancets for Single Use?

The FDA product code for Sterile Lancets for Single Use is QRK.

Other records listing Ningbo Caremed Medical Products Co., Ltd. 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.

K241848MedtFine Safety Lancet

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.K241810MICROLET®NEXT LancetAscensia Diabetes Care U.S., Inc.K232330Lancing SystemNingbo Medsun Medical Co., Ltd.K230712SG Lanset I, SG Lancets, Soft LancetsSewon Medical Co.

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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