FDA 510(k) Application Details - K200865

Device Classification Name	Test,System,Potassium,Enzymatic Method   More FDA Info for this Device
510(K) Number	K200865
Device Name	Test,System,Potassium,Enzymatic Method
Applicant	Abaxis, Inc. 3240 Whipple Road Union City, CA 94587 US Other 510(k) Applications for this Company
Contact	Dennis M Bleile Other 510(k) Applications for this Contact
Regulation Number	862.1600   More FDA Info for this Regulation Number
Classification Product Code	MZV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/01/2020
Decision Date	10/20/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Dual Track
Reviewed By Third Party	N
Expedited Review