# K861387: Kodak Ektachem Clinical Chemistry Slides (CK-MB)

- Pathway: 510(k) (Traditional)
- Applicant: Eastman Kodak Company
- Decided: Jun 27, 1986 after 74 days
- Product code: JHS (Differential Rate Kinetic Method, Cpk Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: 4 (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
- Dec 11, 2020 · Class II · Z-0770-2021: VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference
- Apr 1, 2020 · Class II · Z-1930-2020: The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results.
- Apr 1, 2020 · Class II · Z-1931-2020: The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results.
- Jun 12, 2013 · Class II · Z-0306-2014: 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/K861387
Methodology: https://510kreport.com/methodology