FDA 510(k) Application Details - K050305

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K050305
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	BIOSCREEN MEDICAL INC. RR I BOX 1045A MILDRED, PA 18632 US Other 510(k) Applications for this Company
Contact	JIMMY LIANG 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	02/08/2005
Decision Date	05/23/2005
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