# K812027: Kodak Ektachem Clin. Chem. Slides (Amyl)

- Pathway: 510(k) (Traditional)
- Applicant: Eastman Kodak Company
- Decided: Aug 3, 1981 after 14 days
- Product code: CIW (Starch-Dye Bound Polymer, Amylase)
- Device class: 2
- Regulation: 21 CFR 862.1070
- Recalls of this device: 5 (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
- May 11, 2020 · Class II · Z-2364-2020: Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets
- May 11, 2020 · Class II · Z-2366-2020: Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets
- May 11, 2020 · Class II · Z-2367-2020: Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets
- May 11, 2020 · Class II · Z-2365-2020: Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets
- Jun 12, 2013 · Class II · Z-0298-2014: 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/K812027
Methodology: https://510kreport.com/methodology