FDA 510(k) Application Details - K121040

Device Classification Name	Electrode, Ion Specific, Potassium   More FDA Info for this Device
510(K) Number	K121040
Device Name	Electrode, Ion Specific, Potassium
Applicant	DIAMOND DIAGNOSTICS, INC. 333 FISKE ST. HOLLISTON, MA 01746 US Other 510(k) Applications for this Company
Contact	KATHY CRUZ 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	04/05/2012
Decision Date	08/30/2012
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