# K910642: Cedia (R) Digoxin SC Assay

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: Mar 21, 1991 after 36 days
- Product code: KXT (Enzyme Immunoassay, Digoxin)
- Device class: 2
- Regulation: 21 CFR 862.3320
- 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; 1 cites 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
- K962269: Cedia Cardiac TDM Multi-Cals (1996), 1 descendant of its own
- K972433: Cedia Digoxin Calibrators (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K910642
Methodology: https://510kreport.com/methodology