# K932127: TDX/Tdxflx & Tdxflx Theophylline Monoclonal II

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Aug 9, 1993 after 98 days
- Product code: LGS (Fluorescence Polarization Immunoassay, Theophylline)
- Device class: 2
- Regulation: 21 CFR 862.3880
- Recalls of this device: none
- 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
- K972495: Accumeter Theophylline Test (1997), 0 descendants of its own
- K962294: Immage Immunochemistry System (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K932127
Methodology: https://510kreport.com/methodology