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

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

FDA 510(k) Number	Applicant	Device Name	Decision Date
K221664	Aardvark Medical, Inc.	CLEARinse CTS Specimen Collection and Transport System	07/03/2023
K201849	Copan Italia S.p.A.	eNAT molecular collection and preservation medium	09/17/2020
DEN170029	Longhorn Vaccines and Diagnostics LLC	PrimeStore MTM	03/19/2018
K212113	MagBio Genomics, Inc.	MagXtract Collection Tube	07/28/2022
K221802	Mawi DNA Technologies	iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)	04/03/2023
K211675	Ningbo Dasky Life Science Co., Ltd.	Dasky Disposable Sampling Tube (Model name: VSM02)	08/08/2022
K220059	Shenzhen Dakewe Bio-engineering Co., Ltd.	BiosciÖ Inactivated Transport Medium, BiosciÖ ITM	01/19/2023
K223497	Spectrum Solutions, LLC	Spectrum Saliva Collection Device	02/17/2023
K210440	Wuxi Nest Biotechnology Co., Ltd.	Disposable Sampler Inactivated Transport Media, Nest ITM	09/20/2021
K202641	Zymo Research	DNA/RNA Shield Collection Tube	12/14/2020
K231013	Zymo Research	DNA/RNA Shield SafeCollect Saliva Collection kit	09/28/2023