FDA 510(k) Applications for Medical Device Product Code "QRK"

FDA 510(k) Number Applicant Device Name Decision Date
K230759 Bosungmeditech Co., Ltd. SafeLan« (2 models/SafeLan 26G, SafeLan 30G), SafeLan«-Pro (1 model/SafeLan«-Pro) 06/13/2023
K221433 Facet Technologies LLC Facet 28G Universal Lancet 07/15/2022
K223314 HUAIAN HENING MEDICAL INSTRUMENTS CO., LTD Disposable Blood Lancets 01/25/2023
K223480 Medipoint Holdings, LLC Medipoint Blood Lancets 01/13/2023
K221383 Shanghai Carelife International Trading Co. Ltd. MedtFine Blood Lancet 09/21/2022
K222617 STAT Medical Devices EasyTouch Lancing Device 03/21/2023
K223815 STAT Medical Devices ONE DROP Lancing Device 02/15/2023
K230310 STAT Medical Devices STAT Medical Device Lancing System 09/08/2023
K221507 SteriLance Medical (Suzhou) Inc. Disposable Blood Lancet 08/31/2022


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