# K012878: Thermo Trace Ammonia Standards Set, Models TR-609

- Pathway: 510(k) (Abbreviated)
- Applicant: Thermo Dma, Inc.
- Decided: Oct 16, 2001 after 49 days
- Product code: JIS (Calibrator, Primary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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. Our reading found no predicate number; beside “510(k)” the summary prints a number our reading could not make out (“K(74620”).

## Indications for use
This reagent is intended for use with Thermo Trace Ammonia Reagent(510(k) number K(74620) to establish points of reference that are used in the determination of Ammonia in human plasma.

Source page: https://510kreport.com/device/K012878
Methodology: https://510kreport.com/methodology