FDA 510(k) Application Details - K001154

Device Classification Name	Electrode, Ion Specific, Sodium   More FDA Info for this Device
510(K) Number	K001154
Device Name	Electrode, Ion Specific, Sodium
Applicant	I-STAT CORP. 104 WINDSOR CENTER DR. EAST WINDSOR, NJ 08520 US Other 510(k) Applications for this Company
Contact	PAUL VANDERWERF Other 510(k) Applications for this Contact
Regulation Number	862.1665   More FDA Info for this Regulation Number
Classification Product Code	JGS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/10/2000
Decision Date	04/18/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review