FDA 510(k) Application Details - K182428

Device Classification Name	System, Test, Blood Glucose, Over The Counter   More FDA Info for this Device
510(K) Number	K182428
Device Name	System, Test, Blood Glucose, Over The Counter
Applicant	HMD BioMedical Inc. No. 181 Minsheng St., Xinpu Township Hsin Chu County 30542 TW Other 510(k) Applications for this Company
Contact	Jen Ke-Min 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	09/06/2018
Decision Date	05/08/2019
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