FDA 510(k) Application Details - K013372

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K013372
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	UNIPATH LTD. 390 PARK AVE. NEW YORK, NY 10022-4698 US Other 510(k) Applications for this Company
Contact	STEVEN H ARMSTRONG 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	10/11/2001
Decision Date	11/09/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review