# K840880: Ektachem Clinical Chem. Slides

- Pathway: 510(k) (Traditional)
- Applicant: Eastman Kodak Company
- Decided: Apr 18, 1984 after 51 days
- Product code: CIG (Diazo Colorimetry, Bilirubin)
- Device class: 2
- Regulation: 21 CFR 862.1110
- 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.
19 later devices descend from it; 3 cite it directly.
0 of 20 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
- K991417: Abl 735 Analyzer (1999), 16 descendants of its own
- K093623: Gem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem CVP 2 (Addition of Total Bilirubim Assignment to (2010), 12 descendants of its own
- K112995: Gem Premier 4000 (2012), 11 descendants of its own
- K133407: Gem Premier 4000 (2014), 10 descendants of its own
- K173403: GEM Premier 5000 (2017), 2 descendants of its own

## Recalls of this device
- Jan 9, 2014 · Class II · Z-1226-2014: An incorrect assay value (0.3785) was printed on the product carton for the 460 nm wavelength (filter) that may cause a delay in the ability to obtain and report TBIL, Bu, Bc, and derived tests result
- Jun 12, 2013 · Class II · Z-0324-2014: 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/K840880
Methodology: https://510kreport.com/methodology