FDA 510(k) Applications for Medical Device Product Code: QRL ()

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

FDA 510(k) Number	Applicant	Device Name	Decision Date
K221175	Arkray, Inc.	Multi-Lancet Device 2, ReliOn Premier Lancing Device	10/17/2022
K221546	Asahi Polyslider Co., Ltd.	OneTouch Delica Plus Lancing System	08/23/2022
K220633	Ascensia Diabetes Care US Inc	MICROLET NEXT lancing device, MICROLET Lancet	06/03/2022
K222034	Beijing Ruicheng Medical Supplies Co., Ltd.	RightLance Blood Lancing System	09/07/2022
K221062	Bionime Corporation	RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device	09/26/2022
K222539	Facet Technologies LLC	Facet Blood Lancets	11/18/2022
K223099	Facet Technologies LLC	Facet Manatee Reusable Lancing Base	11/28/2022
K221419	GOSTAR Co., Ltd.	TD-5010 Lancing Device and TD-5084 Sterile Lancets	01/20/2023
K222656	i-SENS, Inc.	LDE4 Lancing Device	11/23/2022
K221613	Owen Mumford Ltd	Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets	10/03/2022
K223643	Promisemed Hangzhou Meditech Co., Ltd.	Verifine« Ease Lancing Device, Verifine« Lancing Device	02/21/2023
K220608	Roche Diabetes Care, Inc	Accu-Chek FastClix Blood Lancing System	04/29/2022
K214022	Roche Diabetes Care, Inc.	Accu-Chek Softclix Blood Lancing System	02/17/2022
K222472	Shandong Lianfa Medical Plastic Products Co. Ltd.	Lancing System, Sterile Lancet for Single Use, Lancing Device	11/30/2022
K221970	SteriLance Medical(Suzhou) Inc.	Lancing device	08/30/2022
K220387	Suzhou Kyuan Medical Apparatus Co., Ltd.	Disposable Blood Lancets	08/17/2022
K220475	Tianjin Huahong Technology Co., Ltd.	Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T)	07/06/2022
K222246	Tianjin Rilifine Medical Device Co., Ltd.	Disposable Sterile Lancet	11/21/2022
K221072	Trividia Health	TRUEdraw Lancing Device, Mini Lancing Device	10/18/2022