# K003583: Lithium Regent Model TR66056 / Lithium Standard TR66901

- Pathway: 510(k) (Traditional)
- Applicant: Trace America, Inc.
- Decided: Jan 17, 2001 after 58 days
- Product code: NDW (Assay, Porphyrin, Spectrophotometry, Lithium)
- Device class: 2
- Regulation: 21 CFR 862.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K063705: Lithium Micro Volume Electrode, Theophylline, Ise Calibrators 1, 2 and 3, TDM Calibration Set B, Nortrol and Abtrol (2007), 0 descendants of its own
- K070987: Sentinel Lithium Assay (2007), 0 descendants of its own
- K033360: Diazyme Lithium Enzymatic Assay Kit (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K003583
Methodology: https://510kreport.com/methodology