FDA 510(k) Application Details - K181675

Device Classification Name	More FDA Info for this Device
510(K) Number	K181675
Device Name	FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System
Applicant	TaiDoc Technology Corporation B1-7F, No. 127, Wugong 2nd Rd., Wugu District New Taipei City 24888 TW Other 510(k) Applications for this Company
Contact	Yvette Chang Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PTC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/25/2018
Decision Date	12/10/2018
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