# K760332: Sigma Ammonia Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Chemical Co.
- Decided: Aug 23, 1976 after 26 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K021151: Ammonia Assay for the Advia Integrated Modular System (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K760332
Methodology: https://510kreport.com/methodology