FDA 510(k) Application Details - K013874

Device Classification Name	Radioimmunoassay, Luteinizing Hormone   More FDA Info for this Device
510(K) Number	K013874
Device Name	Radioimmunoassay, Luteinizing Hormone
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	862.1485   More FDA Info for this Regulation Number
Classification Product Code	CEP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/2001
Decision Date	02/19/2002
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