FDA 510(k) Application Details - K032159

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K032159
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	ACCESS BIO INCORPORATE 675 US HIGHWAY 1 NORTH BRUNSWICK, NJ 08902 US Other 510(k) Applications for this Company
Contact	YOUNG HO CHOI 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	07/15/2003
Decision Date	09/05/2003
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