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FDA 510(k)

MedtFine Blood Lancet

K-Number: K221383 · 2022-09-21

ApplicantShanghai Carelife International Trading Co. , Ltd.
Decision Date2022-09-21
Product CodeQRK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MedtFine Blood Lancet is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Carelife International Trading Co. , Ltd.. It received FDA 510(k) clearance on 2022-09-21 under 510(k) number K221383. 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 MedtFine Blood Lancet?

MedtFine Blood Lancet is a medical device that received FDA 510(k) clearance on 2022-09-21. The listed applicant is Shanghai Carelife International Trading Co. , Ltd.. The 510(k) number is K221383.

When did MedtFine Blood Lancet receive FDA 510(k) clearance?

MedtFine Blood Lancet received FDA 510(k) clearance on 2022-09-21, under 510(k) number K221383.

Who is the listed applicant for MedtFine Blood Lancet?

The FDA 510(k) record lists Shanghai Carelife International Trading Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MedtFine Blood Lancet?

The FDA product code for MedtFine Blood Lancet is QRK.

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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