# K904226: 'Tdxflx Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Oct 29, 1990 after 46 days
- Product code: LCQ (Fluorescent Immunoassay Gentamicin)
- Device class: 2
- Regulation: 21 CFR 862.3450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 6 cite it directly.
0 of 9 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
- K962519: Emit 2000 Gentamicin Assay and Calibrators (1996), 1 descendant of its own
- K961256: Synchron Systems Valproic Acid (Vpa) Reagent (1996), 1 descendant of its own
- K060709: Multigent Gentamicin (2006), 0 descendants of its own
- K042479: Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros Chemistyr Products Calibrator Kits 11, 13 & 14; Vitros Che (2005), 0 descendants of its own
- K031870: Synchron Systems Valproic Acid (V-PA) Reagent (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K904226
Methodology: https://510kreport.com/methodology