# K984402: Synchron Systems Ammonia (Amm) Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Jan 29, 1999 after 51 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
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.

## Recalls of this device
- Mar 26, 2009 · Not classified · Z-1432-2012: The Ammonia Reagent lot M808278 may fail calibration or cause a low shift in Quality Control recovery on some SYNCHRON Systems.

## Indications for use
The SYNCHRON® Systems Ammonia (AMM) Reagent, in conjunction with SYNCHRON® Systems Ammonia Calibrators, is intended for the quantitative determination of ammonia concentration in plasma on SYNCHRON® Systems.

Source page: https://510kreport.com/device/K984402
Methodology: https://510kreport.com/methodology