# K844070: TDX Salicylate

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Nov 27, 1984 after 40 days
- Product code: DKJ (Colorimetry, Salicylate)
- Device class: 2
- Regulation: 21 CFR 862.3830
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K020794: Salicylate Assay for the Advia Integrated Modular System (2002), 0 descendants of its own
- K014173: Synchron Systems Salicylate Reagent and Calibrator (2002), 0 descendants of its own

## Recalls of this device
- Dec 5, 2003 · Not classified · Z-0509-04: The reagent package inserts for the products contain incorrect information in the Specific Performance Characteristics section. % Recovery incorrect.

Source page: https://510kreport.com/device/K844070
Methodology: https://510kreport.com/methodology