MZV · Class II · 21 CFR 862.1600

FDA Product Code MZV: Test, System, Potassium, Enzymatic Method

Leading manufacturers include 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
1–4 of 4
Cleared Oct 20, 2021
Piccolo Potassium Test System
K200865
Abaxis, Inc.
Chemistry · 567d

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.

MZV devices are reviewed by the Chemistry panel. Browse all Chemistry devices →