FDA 510(k) Application Details - K060019

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K060019
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	ARTRON LABORATORIES, INC. 3938 NORTH FRASER WAY BURNABY, BRITISH COLUMBIA V5J 5H6 CA Other 510(k) Applications for this Company
Contact	JERRY ZHENG 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	01/04/2006
Decision Date	02/17/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review