FDA 510(k) Application Details - K023638

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K023638
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	IND DIAGNOSTIC INC. 1629 FOSTERS WAY DELTA, BC V3M 6S7 CA Other 510(k) Applications for this Company
Contact	DAVID LEE 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	10/30/2002
Decision Date	01/03/2003
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