# K934071: Kodak Ektachem DT Slides (Urcr)

- Pathway: 510(k) (Traditional)
- Applicant: Eastman Kodak Company
- Decided: Mar 21, 1994 after 213 days
- Product code: CGX (Alkaline Picrate, Colorimetry, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: 1 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K071215: Vitros Chemistry Products Urcr Slides, Vitros Chemistry Products DT Calibrator Kit, Model 680 2722, 195 7927 (2007), 0 descendants of its own

## Recalls of this device
- Oct 13, 2011 · Not classified · Z-0917-2012: Ortho Clinical Diagnostics (OCD) was notified by customers of negatively biased quality control results obtained while using VITROS Chemistry Products NBIL DT Slides, GEN 72. OCD performed an internal

Source page: https://510kreport.com/device/K934071
Methodology: https://510kreport.com/methodology