FDA 510(k) Application Details - K961024

Device Classification Name	System, Test, Infectious Mononucleosis   More FDA Info for this Device
510(K) Number	K961024
Device Name	System, Test, Infectious Mononucleosis
Applicant	PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 MONMOUTH JUNCTION, NJ 08852-1905 US Other 510(k) Applications for this Company
Contact	JENO KANG, PH.D. Other 510(k) Applications for this Contact
Regulation Number	866.5640   More FDA Info for this Regulation Number
Classification Product Code	KTN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/14/1996
Decision Date	02/04/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review