FDA 510(k) Application Details - K053597

Device Classification Name	Test,Natriuretic Peptide   More FDA Info for this Device
510(K) Number	K053597
Device Name	Test,Natriuretic Peptide
Applicant	I-STAT CORPORATION 104 WINDSOR CENTER DRIVE EAST WINDSOR, NJ 08520 US Other 510(k) Applications for this Company
Contact	SUE KENT 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	12/23/2005
Decision Date	07/21/2006
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