FDA 510(k) Application Details - K072189

Device Classification Name	Test,Natriuretic Peptide   More FDA Info for this Device
510(K) Number	K072189
Device Name	Test,Natriuretic Peptide
Applicant	MITSUBISHI KAGAKU IATRON 701 FIFTH AVENUE FLOOR 42 SEATTLE, WA 98104 US Other 510(k) Applications for this Company
Contact	HELEN LANDICHO Other 510(k) Applications for this Contact
Regulation Number	862.1117   More FDA Info for this Regulation Number
Classification Product Code	NBC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/06/2007
Decision Date	02/05/2008
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