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FDA 510(k)

Verifine® Ease Lancing Device, Verifine® Lancing Device

K-Number: K223643 · 2023-02-21

Decision Date2023-02-21
Product CodeQRL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Verifine® Ease Lancing Device, Verifine® Lancing Device is a medical device manufactured by Promisemed Hangzhou Meditech Co., Ltd.. It received FDA 510(k) clearance on 2023-02-21 under approval number K223643. 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 Verifine® Ease Lancing Device, Verifine® Lancing Device?

Verifine® Ease Lancing Device, Verifine® Lancing Device is a medical device that received FDA 510(k) clearance on 2023-02-21. It is manufactured by Promisemed Hangzhou Meditech Co., Ltd.. The 510(k) number is K223643.

When was Verifine® Ease Lancing Device, Verifine® Lancing Device approved by the FDA?

Verifine® Ease Lancing Device, Verifine® Lancing Device received FDA 510(k) clearance on 2023-02-21, under approval number K223643.

What company makes Verifine® Ease Lancing Device, Verifine® Lancing Device?

Verifine® Ease Lancing Device, Verifine® Lancing Device is manufactured by Promisemed Hangzhou Meditech Co., Ltd..

What is the FDA product code for Verifine® Ease Lancing Device, Verifine® Lancing Device?

The FDA product code for Verifine® Ease Lancing Device, Verifine® Lancing Device is QRL.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.