FDA 510(k) Application Details - K211675

Device Classification Name	More FDA Info for this Device
510(K) Number	K211675
Device Name	Dasky Disposable Sampling Tube (Model name: VSM02)
Applicant	Ningbo Dasky Life Science Co., Ltd. No. 6, Donggong 1st Road, Yinzhou District Ningbo 315000 CN Other 510(k) Applications for this Company
Contact	Wilson Wong Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QBD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2021
Decision Date	08/08/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review