# K964565: Paramax Ammonia and Ammonia Blank Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Dade Intl., Inc.
- Decided: Nov 22, 1996 after 8 days
- Product code: JIF (Enzymatic Method, Ammonia)
- Device class: 1
- Regulation: 21 CFR 862.1065
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K770363 (1977). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K770363: Aca Ammonia Analytical Test Pack, E.I. Dupont DE Nemours & Co., Inc. (1977) Summary page 1.

## Indications for use
The proposed and the predicate device are intended for use as quantitative determination of Ammonia and Ammonia Blank in plasma.

Source page: https://510kreport.com/device/K964565
Methodology: https://510kreport.com/methodology