FDA 510(k) Application Details - K972457

Device Classification Name	System, Test, Infectious Mononucleosis   More FDA Info for this Device
510(K) Number	K972457
Device Name	System, Test, Infectious Mononucleosis
Applicant	IMMUNOSTICS, INC. 3505 SUNSET AVE. OCEAN, NJ 07712 US Other 510(k) Applications for this Company
Contact	DAVID MYCOCK 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	07/01/1997
Decision Date	12/01/1997
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