FDA 510(k) Application Details - K100017

Device Classification Name	More FDA Info for this Device
510(K) Number	K100017
Device Name	EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM
Applicant	EUROIMMUN US INC 95 WASHINGTON ST MORRISTOWN, NJ 07960 US Other 510(k) Applications for this Company
Contact	KATHRYN KOHL Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OSK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/04/2010
Decision Date	09/13/2010
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