FDA 510(k) Application Details - K222126

Device Classification Name	System, Test, Blood Glucose, Over The Counter   More FDA Info for this Device
510(K) Number	K222126
Device Name	System, Test, Blood Glucose, Over The Counter
Applicant	Vivachek Biotech (Hangzhou) Co., Ltd Level 2, Block 2, 146 East Chaofeng Road Yuhang Econimic Development Zone Hangzhou 311100 CN Other 510(k) Applications for this Company
Contact	Mark Qian Other 510(k) Applications for this Contact
Regulation Number	862.1345   More FDA Info for this Regulation Number
Classification Product Code	NBW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/18/2022
Decision Date	08/16/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review