# K812030: Kodak Ektachem Clin. Chem. Slides (Alb)

- Pathway: 510(k) (Traditional)
- Applicant: Eastman Kodak Company
- Decided: Aug 3, 1981 after 14 days
- Product code: CIX (Bromcresol Green Dye-Binding, Albumin)
- Device class: 2
- Regulation: 21 CFR 862.1035
- 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.
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
- K023875: Vitros Chemistry Products Alb Slide, Vitros Chemistry Products Calibrator Kit 4 (2002), 1 descendant of its own
- K191316: VITROS XT Chemistry Products ALB-TP Slides (2019), 0 descendants of its own

## Recalls of this device
- Jun 12, 2013 · Class II · Z-0294-2014: Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

Source page: https://510kreport.com/device/K812030
Methodology: https://510kreport.com/methodology