# K091455: Diazyme Liquid Stable Enzymatic Potassium Assay Kit, Model DZ113C-X, Diazyme Liquid Stable Enzymatic Potassium Assay Cal

- Pathway: 510(k) (Traditional)
- Applicant: Diazyme Laboratories
- Decided: Aug 14, 2009 after 88 days
- Product code: MZV (Test, System, Potassium, Enzymatic Method)
- Device class: 2
- Regulation: 21 CFR 862.1600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
For in vitro quantitative determination of potassium in human serum. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. For IVD use only. The Diazyme Liquid Stable Enzymatic Potassium Assay Calibrator Kit is intended for use in the calibration of quantitative Diazyme Liquid Stable Enzymatic Potassium Assay Kit (DZ1 13C). For IVD use only. The Diazyme Liquid Stable Enzymatic Potassium Assay Control Kit is intended for use as quality controls for the Diazyme Liquid Stable Enzymatic Potassium Assay (DZ 113C). For IVD use only.

Source page: https://510kreport.com/device/K091455
Methodology: https://510kreport.com/methodology