FDA 510(k) Application Details - K212878

Device Classification Name	More FDA Info for this Device
510(K) Number	K212878
Device Name	Sample preservation solution
Applicant	Zhejiang GENE SCIENCE Co., Ltd. No.2 Workshop,Pharmaceutical Industrial Park,No.11 Shengxing Road,Shangyu Economic Tech Shaoxing 312300 CN Other 510(k) Applications for this Company
Contact	Zhang Feng 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	09/09/2021
Decision Date	04/08/2024
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