FDA 510(k) Application Details - K963693

Device Classification Name	Radioimmunoassay, Luteinizing Hormone   More FDA Info for this Device
510(K) Number	K963693
Device Name	Radioimmunoassay, Luteinizing Hormone
Applicant	PRINCETON BIOMEDITECH CORP. P.O. BOX 7139 PRINCETON, NJ 08543-7139 US Other 510(k) Applications for this Company
Contact	JEMO KANG, PH.D. 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	09/16/1996
Decision Date	11/29/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review