FDA 510(k) Application Details - K112412

Device Classification Name	Electrode, Ion Specific, Potassium   More FDA Info for this Device
510(K) Number	K112412
Device Name	Electrode, Ion Specific, Potassium
Applicant	BECKMAN COULTER, INC. 250 S. KRAEMER BOULEVARD MAIL STOP E2 SE08 BREA, CA 92821 US Other 510(k) Applications for this Company
Contact	DAVID G DAVIS 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	08/22/2011
Decision Date	12/23/2011
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