510(k) · Cleared
Recalled · Class II · 2020Kodak Ektachem Clinical Chemistry Slides (CK-MB)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eastman Kodak Company · JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes
Cleared on Jun 27, 1986 after a 74-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 4 times.
- Decided
- Jun 27, 1986
- Review
- 74 days
- Class
- Class II
- Product code
- JHS
- Recalls
- 4
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JHS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 11, 2020 | Class II | Z-0770-2021 | Under Investigation by firm | VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference |
| Apr 1, 2020 | Class II | Z-1930-2020 | Labeling design | 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 | Labeling design | 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 | Equipment maintenance | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All JHS devicesJHS Differential Rate Kinetic Method, Cpk Or Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JHS
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JHS
Too few JHS 510(k)s in any year since 2007 to give a median.
Recalls per year · JHS
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JHS
10in 2025
MAUDE reports naming product code JHS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 11 |
| 2010 | 0 | — | 0 | 26 |
| 2011 | 1 | — | 0 | 18 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 2 | 2 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 5 | 6 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 1 | 13 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 14 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K861387 · printed Nov 4, 2026
Cite this page
510(k) Report. “K861387: Kodak Ektachem Clinical Chemistry Slides (CK-MB).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K861387
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026