FDA 510(k) Application Details - K974784

Device Classification Name	Electrode, Ion Specific, Potassium   More FDA Info for this Device
510(K) Number	K974784
Device Name	Electrode, Ion Specific, Potassium
Applicant	AVL SCIENTIFIC CORP. 33 MANSELL COURT ROSWELL, GA 30076-4807 US Other 510(k) Applications for this Company
Contact	RANDY BYRD Other 510(k) Applications for this Contact
Regulation Number	862.1600   More FDA Info for this Regulation Number
Classification Product Code	CEM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/1997
Decision Date	02/24/1998
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