FDA 510(k) Application Details - K983113

Device Classification Name	Radioimmunoassay, Luteinizing Hormone   More FDA Info for this Device
510(K) Number	K983113
Device Name	Radioimmunoassay, Luteinizing Hormone
Applicant	SYNTRON BIORESEARCH, INC. 2774 LOKER AVE. WEST CARLSBAD, CA 92008 US Other 510(k) Applications for this Company
Contact	CHARLES YU 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	09/04/1998
Decision Date	11/18/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review