FDA 510(k) Application Details - K030659

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K030659
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	UNIPATH LTD. PRIORY BUSINESS PARK BEDFORD MK44 3UP GB Other 510(k) Applications for this Company
Contact	Louise Roberts 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	03/03/2003
Decision Date	05/02/2003
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