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FDA 510(k)

STAT Medical Device Lancing System

K-Number: K230310 · 2023-09-08

ApplicantStat Medical Devices
Decision Date2023-09-08
Product CodeQRK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STAT Medical Device Lancing System is a medical device manufactured by Stat Medical Devices. It received FDA 510(k) clearance on 2023-09-08 under approval number K230310. 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 STAT Medical Device Lancing System?

STAT Medical Device Lancing System is a medical device that received FDA 510(k) clearance on 2023-09-08. It is manufactured by Stat Medical Devices. The 510(k) number is K230310.

When was STAT Medical Device Lancing System approved by the FDA?

STAT Medical Device Lancing System received FDA 510(k) clearance on 2023-09-08, under approval number K230310.

What company makes STAT Medical Device Lancing System?

STAT Medical Device Lancing System is manufactured by Stat Medical Devices.

What is the FDA product code for STAT Medical Device Lancing System?

The FDA product code for STAT Medical Device Lancing System is QRK.

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Related PubMed Literature

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Other Devices by Stat Medical Devices

K222617EasyTouch Lancing Device K223815ONE DROP Lancing Device

Related Devices (Code: QRK)

K221383MedtFine Blood LancetShanghai Carelife International Trading Co. , Ltd. K221507Disposable Blood LancetSteriLance Medical (Suzhou), Inc. K221433Facet 28G Universal LancetFacet Technologies, LLC K230712SG Lanset I, SG Lancets, Soft LancetsSewon Medical Co. K230759SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro)Bosungmeditech Co., Ltd. K222617EasyTouch Lancing DeviceStat Medical Devices

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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