FDA 510(k) Application Details - K200913

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K200913
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	SPD Swiss Precision Diagnostics GmbH 47 Route de St Georges, Petit-Lancey Geneva ch-1213 CH Other 510(k) Applications for this Company
Contact	Joanne Scaife 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	04/06/2020
Decision Date	08/13/2021
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