# K841503: Kodak Ektachem DT 60 Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Eastman Kodak Company
- Decided: May 22, 1984 after 42 days
- Product code: JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2160
- Recalls of this device: 2 (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
- Sep 27, 2006 · Not classified · Z-0151-2007: Positively biased results when using the VITROS Chemistry Products GLU DT Slides GEN 56.
- Jul 28, 2003 · Not classified · Z-1225-03: Results of glucose measurements on sodium fluoride/potassium oxalate specimens can be negatively biased when using Vitros GLU and GLU DT slides stored in the refrigerator.

Source page: https://510kreport.com/device/K841503
Methodology: https://510kreport.com/methodology