# K942610: Kodak Extachem Clinical Chemistry Slide Digoxin (DGXN)

- Pathway: 510(k) (Traditional)
- Applicant: Eastman Kodak Company
- Decided: Oct 20, 1994 after 140 days
- Product code: LFM (Enzyme Immunoassay, Digitoxin)
- Device class: 2
- Regulation: 21 CFR 862.3300
- Recalls of this device: 4 (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
- Dec 5, 2024 · Class II · Z-0901-2025: Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.
- Dec 5, 2024 · Class II · Z-0902-2025: Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.
- Jun 12, 2013 · Class II · Z-0310-2014: Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.
- Jun 28, 2012 · Class II · Z-2211-2012: Ortho Clinical Diagnostics revised the VITROS Chemistry Products DGXN Slides Instructions for Use (IFU) and removed heparin plasma as a recommended specimen type for VITROS DGXN Slides

Source page: https://510kreport.com/device/K942610
Methodology: https://510kreport.com/methodology