FDA 510(k) Application Details - K123986

Device Classification Name	Immunoassay, Insulin-Like Growth Factor Binding Protein-1   More FDA Info for this Device
510(K) Number	K123986
Device Name	Immunoassay, Insulin-Like Growth Factor Binding Protein-1
Applicant	ALERE SCARBOROUGH, INC 10 Southgate Road Scarborough, ME 04074 US Other 510(k) Applications for this Company
Contact	Angela Drysdale Other 510(k) Applications for this Contact
Regulation Number	862.1550   More FDA Info for this Regulation Number
Classification Product Code	OAM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/2012
Decision Date	01/09/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review