# K033921: Ammonia-L3K Assay, Catalogue Number 233-10

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Chemicals, Ltd.
- Decided: Mar 10, 2004 after 83 days
- Product code: JIF (Enzymatic Method, Ammonia)
- Device class: 1
- Regulation: 21 CFR 862.1065
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Nov 29, 2016 · Class II · Z-1078-2017: Certain lots are showing an atypical decrease in optical density (OD) over time, which may result in an impact to performance at the high end of the linear range.

## Indications for use
For the [N VITRO quantitative determination of Ammonia in plasma. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Rev'> Syndrome. For the IN VITRO qumatitaitive dcetermination of Anminonia in plasma.

Source page: https://510kreport.com/device/K033921
Methodology: https://510kreport.com/methodology