FDA 510(k) Application Details - K042347

Device Classification Name	Test,Natriuretic Peptide   More FDA Info for this Device
510(K) Number	K042347
Device Name	Test,Natriuretic Peptide
Applicant	DADE BEHRING, INC. BLDG. 500 MAIL BOX 514 P.O. BOX 6101 NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	GEORGE M PLUMMER 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	08/30/2004
Decision Date	11/19/2004
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