FDA 510(k) Application Details - K200544

Device Classification Name	Electrode, Ion Specific, Potassium   More FDA Info for this Device
510(K) Number	K200544
Device Name	Electrode, Ion Specific, Potassium
Applicant	Diamond Diagnostics Inc. 333 Fiske Street Holliston, MA 01746 US Other 510(k) Applications for this Company
Contact	Kathy Fisher 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	03/03/2020
Decision Date	10/01/2020
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