FDA 510(k) Application Details - K122907

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K122907
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	POLYMED THERAPEUTICS, INC 27001 LA PAZ ROAD, SUITE 266B MISSION VIEJO, CA 92691 US Other 510(k) Applications for this Company
Contact	TERRI WALLACE 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	09/21/2012
Decision Date	03/14/2013
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