FDA 510(k) Application Details - K994112

Device Classification Name	System, Test, Her-2/Neu, Monitoring   More FDA Info for this Device
510(K) Number	K994112
Device Name	System, Test, Her-2/Neu, Monitoring
Applicant	ONCOGENE SCIENCE, INC. 80 ROGERS ST. CAMBRIDGE, MA 02142 US Other 510(k) Applications for this Company
Contact	WALTER P CARNEY Other 510(k) Applications for this Contact
Regulation Number	866.6010   More FDA Info for this Regulation Number
Classification Product Code	NCW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/06/1999
Decision Date	09/29/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review