Product code MZV— Clinical Chemistry

DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL

Classification name
Test, System, Potassium, Enzymatic Method
Device class
Class 2
Regulation
21 CFR 862.1600
Advisory panel
Clinical Chemistry
Total cleared
4
First cleared
Most recent

Market context for product code MZV

FDA has cleared 4 devices under product code MZV between 2004 and 2021, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code MZV

Recent clearances under product code MZV

Data sourced from openFDA. This site is unofficial and independent of the FDA.