# K833070: TDX Theophylline

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Nov 14, 1983 after 67 days
- Product code: LER (Fluorescent Immunoassay, Theophylline)
- Device class: 2
- Regulation: 21 CFR 862.3880
- 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.
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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Apr 11, 2007 · Not classified · Z-0958-2007: A decrease in mP values (calibration curve Net Polarization value) has been observed with this reagent lot at all calibrator levels and may produce the following results: Calibration Error Code 148 (P

Source page: https://510kreport.com/device/K833070
Methodology: https://510kreport.com/methodology