FDA 510(k) Application Details - K980249

Device Classification Name	Radioimmunoassay, Tricyclic Antidepressant Drugs   More FDA Info for this Device
510(K) Number	K980249
Device Name	Radioimmunoassay, Tricyclic Antidepressant Drugs
Applicant	PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 MONMOUTH JUNCTION, NJ 08852-1905 US Other 510(k) Applications for this Company
Contact	JEMO KANG Other 510(k) Applications for this Contact
Regulation Number	862.3910   More FDA Info for this Regulation Number
Classification Product Code	LFG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/23/1998
Decision Date	03/13/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review