FDA 510(k) Application Details - K181551

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K181551
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	Runbio BioTech Co.,Ltd Rongsheng Technological Zone, University Road Shantou 515063 CN Other 510(k) Applications for this Company
Contact	Lyn Chen Other 510(k) Applications for this Contact
Regulation Number	862.1155   More FDA Info for this Regulation Number
Classification Product Code	LCX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/13/2018
Decision Date	02/22/2019
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