FDA 510(k) Application Details - K210440

Device Classification Name	More FDA Info for this Device
510(K) Number	K210440
Device Name	Disposable Sampler Inactivated Transport Media, Nest ITM
Applicant	Wuxi Nest Biotechnology Co., Ltd. No. 530 Xida Road, New District Wuxi 214012 CN Other 510(k) Applications for this Company
Contact	Cheng Zhiwei 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	02/12/2021
Decision Date	09/20/2021
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