# K951169: Ciba Corining Acs Theophylline Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Ciba Corning Diagnostics Corp.
- Decided: Jun 20, 1995 after 97 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K013272: Acs: 180 and Advia Centaur Theophylline 2 Assay (2001), 0 descendants of its own

Source page: https://510kreport.com/device/K951169
Methodology: https://510kreport.com/methodology