FDA 510(k) Application Details - K081767

Device Classification Name	Immunoassay, Placental Alpha-1 Microglobulin (Pamg-1)   More FDA Info for this Device
510(K) Number	K081767
Device Name	Immunoassay, Placental Alpha-1 Microglobulin (Pamg-1)
Applicant	AMNISURE INTERNATIONAL, LLC 30 JFK STREET , 4TH FLOOR CAMBRIDGE, MA 02138 US Other 510(k) Applications for this Company
Contact	MICHAEL FRIEDMAN Other 510(k) Applications for this Contact
Regulation Number	862.1550   More FDA Info for this Regulation Number
Classification Product Code	NQM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/2008
Decision Date	01/09/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review