FDA 510(k) Application Details - K070183

Device Classification Name	Insulin Autoantibody Kit   More FDA Info for this Device
510(K) Number	K070183
Device Name	Insulin Autoantibody Kit
Applicant	KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. 12554 WEST BRIDGER ST. SUITE 108 BOISE, ID 83713 US Other 510(k) Applications for this Company
Contact	HEATHER VIELE Other 510(k) Applications for this Contact
Regulation Number	866.5660   More FDA Info for this Regulation Number
Classification Product Code	OCN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/19/2007
Decision Date	07/13/2007
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