FDA 510(k) Application Details - K111956

Device Classification Name	More FDA Info for this Device
510(K) Number	K111956
Device Name	KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT
Applicant	KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. 170 S SENECA SPRINGS WAY SUITE 105 STAR, ID 83669 US Other 510(k) Applications for this Company
Contact	HEATHER VIELE Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PAF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/11/2011
Decision Date	05/30/2012
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