FDA 510(k) Application Details - K061886

Device Classification Name	Immunoassay, Insulin-Like Growth Factor Binding Protein-1   More FDA Info for this Device
510(K) Number	K061886
Device Name	Immunoassay, Insulin-Like Growth Factor Binding Protein-1
Applicant	MEDIX BIOCHEMICA 49 PLAIN STREET NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	CYNTHIA SINCLAIR 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	07/03/2006
Decision Date	01/25/2007
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