# K972433: Cedia Digoxin Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jul 24, 1997 after 24 days
- Product code: DLJ (Calibrators, Drug Specific)
- Device class: 2
- Regulation: 21 CFR 862.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K830206 (1983). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962269: Cedia Cardiac TDM Multi-Cals, Boehringer Mannheim Corp. (1996) Summary page 1.

## Indications for use
The CEDIA Digoxin Calibrators are used to calibrate the CEDIA Digoxin II assay on the Synchron. The CEDIA Digoxin Calibrators are used to determine drug concentrations.

Source page: https://510kreport.com/device/K972433
Methodology: https://510kreport.com/methodology