# K845027: Kodak Ektachem Clinical Chemistry Slides

- Pathway: 510(k) (Traditional)
- Applicant: Eastman Kodak Company
- Decided: Jan 18, 1985 after 22 days
- Product code: CHI (Lipase-Esterase, Enzymatic, Photometric, Lipase)
- Device class: 1
- Regulation: 21 CFR 862.1465
- 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.
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
- Oct 9, 2006 · Not classified · Z-0245-2007: The firm identified circumstances in which biased results or calibration failures can be observed when using any lot of VITROS LIPA slides if they have been stored on the VITROS Chemistry Systems for 

Source page: https://510kreport.com/device/K845027
Methodology: https://510kreport.com/methodology