FDA 510(k) Application Details - K182328

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K182328
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	True Diagnostics, Inc. 2782 Loker Ave West Carlsbad, CA 92010 US Other 510(k) Applications for this Company
Contact	Jerry 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	08/27/2018
Decision Date	05/15/2019
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