FDA 510(k) Application Details - K080269

Device Classification Name	Test,Natriuretic Peptide   More FDA Info for this Device
510(K) Number	K080269
Device Name	Test,Natriuretic Peptide
Applicant	BIOSITE INCORPORATED 9975 SUMMERS RIDGE RD SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	DAWN A ALLENBY 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	02/01/2008
Decision Date	06/06/2008
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