FDA 510(k) Application Details - K190189

Device Classification Name	System, Test, Blood Glucose, Over The Counter   More FDA Info for this Device
510(K) Number	K190189
Device Name	System, Test, Blood Glucose, Over The Counter
Applicant	EPS Bio Technology Corp. No. 8 R&D RD.III Hsinchu Science Park Hsinchu 30077 TW Other 510(k) Applications for this Company
Contact	Cynthia Hung 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	02/01/2019
Decision Date	11/01/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review