FDA 510(k) Application Details - K133002

Device Classification Name	System, Test, Human Chorionic Gonadotropin   More FDA Info for this Device
510(K) Number	K133002
Device Name	System, Test, Human Chorionic Gonadotropin
Applicant	ABBOTT POINT OF CARE INC. 400 COLLEGE ROAD EAST PRINCETON, NJ 08540 US Other 510(k) Applications for this Company
Contact	MELISSA ROBINSON Other 510(k) Applications for this Contact
Regulation Number	862.1155   More FDA Info for this Regulation Number
Classification Product Code	DHA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/24/2013
Decision Date	04/16/2015
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