FDA 510(k) Application Details - K192123

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K192123
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	Qingdao Hightop Biotech Co., Ltd. No. 369 Hedong Road, Hi-tech Industrial Development Zone Qingdao 266112 CN Other 510(k) Applications for this Company
Contact	Allen Lee 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	08/06/2019
Decision Date	09/05/2019
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