FDA Product Code MZV: Test, System, Potassium, Enzymatic Method
Leading manufacturers include Diazyme Laboratories and Abaxis, Inc..
4
Total
4
Cleared
197d
Avg days
2004
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Test, System, Potassium, Enzymatic Method Devices (Product Code MZV)
4 devices
Cleared
Oct 20, 2021
Piccolo Potassium Test System
Abaxis, Inc.
Chemistry
567d
Cleared
Aug 14, 2009
DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL
Diazyme Laboratories
Chemistry
88d
Cleared
Feb 15, 2006
MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A
Diazyme Laboratories
Chemistry
55d
Cleared
Oct 29, 2004
DIAZYME POTASSIUM ENZYMATIC ASSAY KIT
Diazyme Laboratories
Chemistry
78d
About Product Code MZV - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code MZV since 2004, with 4 receiving FDA clearance (average review time: 197 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.