FDA 510(k) Application Details - K041748

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K041748
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	AZOG, INC. 1011 US HWY 22 PHILLIPSBURG, NJ 08865 US Other 510(k) Applications for this Company
Contact	AZUBUIKE OGALA 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	06/29/2004
Decision Date	08/09/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review