FDA 510(k) Application Details - K213061

Device Classification Name	System, Test, Blood Glucose, Over The Counter   More FDA Info for this Device
510(K) Number	K213061
Device Name	System, Test, Blood Glucose, Over The Counter
Applicant	OK BioTech Co., Ltd. No. 91, Sec. 2, Gongdao 5th Rd. Hsinchu City 30070 TW Other 510(k) Applications for this Company
Contact	Laurie Liu 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	09/22/2021
Decision Date	10/07/2022
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