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 a medical device manufactured by Stat Medical Devices. It received FDA 510(k) clearance on 2023-02-15 under approval 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. It is manufactured by Stat Medical Devices. The 510(k) number is K223815.
When was ONE DROP Lancing Device approved by the FDA?
ONE DROP Lancing Device received FDA 510(k) clearance on 2023-02-15, under approval number K223815.
What company makes ONE DROP Lancing Device?
ONE DROP Lancing Device is manufactured by Stat Medical Devices.
What is the FDA product code for ONE DROP Lancing Device?
The FDA product code for ONE DROP Lancing Device is QRK.
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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.