FDA 510(k) Application Details - K031798

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K031798
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	STANDARD DIAGNOSTICS, INC. 30 NORTHPORT ROAD SOUND BEACH, NY 11789-1734 US Other 510(k) Applications for this Company
Contact	RICHARD C LANZILLOTTO 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	06/10/2003
Decision Date	11/12/2003
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