FDA 510(k) Application Details - K131931

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K131931
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	CHEMTRON BIOTECH, INC. 8370 JUNIPER CREEK LANE SUITE 1-2 SAN DIEGO, CA 92126 US Other 510(k) Applications for this Company
Contact	Jane Zhang 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	06/27/2013
Decision Date	07/26/2013
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