FDA 510(k) Applications for Medical Device Product Code "MZV"
(Test,System,Potassium,Enzymatic Method)

FDA 510(k) Number Applicant Device Name Decision Date
K200865 Abaxis, Inc. Piccolo Potassium Test System 10/20/2021
K091455 DIAZYME LABORATORIES DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL 08/14/2009
K042191 DIAZYME LABORATORIES DIAZYME POTASSIUM ENZYMATIC ASSAY KIT 10/29/2004
K053566 DIAZYME LABORATORIES MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A 02/15/2006


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