510(k) · Cleared
Recalled · Class II · 2013Kodak Ektachem Clinical Chemistry Slides (MG)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eastman Kodak Company · JGJ Photometric Method, Magnesium
Cleared on Aug 26, 1986 after a 134-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it. It has been recalled once.
- Decided
- Aug 26, 1986
- Review
- 134 days
- Class
- Class I
- Product code
- JGJ
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK861386 Kodak Ektachem Clinical Chemistry Slides (MG)Eastman Kodak Company · 1986
- Descendant · cites it directly · 2 of its ownK023876 Vitros Chemistry Products MG Slide, Vitros Chemistry Products…Ortho-Clinical Diagnostics, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 1 of its ownK072440 Vitros Chemistry Products: CA Slides (Model: 145 0261), Calibrators…Ortho-Clinical Diagnostics, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 0 of its ownK190520 VITROS XT Chemistry Products GLU-Ca SlidesOrtho-Clinical Diagnostics, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK040115 Piccolo Magnesium Test SystemAbaxis, Inc. · 2004
Most influential descendants
Showing 4 of 4 · See all- K023876Vitros Chemistry Products MG Slide, Vitros Chemistry Products Calibrator Kit 1Ortho-Clinical Diagnostics, Inc. · 2002 · cites it directly2descendants
- K072440Vitros Chemistry Products: CA Slides (Model: 145 0261), Calibrators Kit 1 (Model: 188…Ortho-Clinical Diagnostics, Inc. · 2007 · 2 generations on1descendant
- K190520VITROS XT Chemistry Products GLU-Ca SlidesOrtho-Clinical Diagnostics, Inc. · 2019 · 3 generations on0descendants
- K040115Piccolo Magnesium Test SystemAbaxis, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K861386 | Kodak Ektachem Clinical Chemistry Slides (MG) | Eastman Kodak Company | 1986 | — |
| +1 | K023876 | Vitros Chemistry Products MG Slide, Vitros Chemistry Products Calibrator Kit 1 | Ortho-Clinical Diagnostics, Inc. | 2002 | 1 |
| +2 | K072440 | Vitros Chemistry Products: CA Slides (Model: 145 0261), Calibrators Kit 1… | Ortho-Clinical Diagnostics, Inc. | 2007 | 4 |
| +3 | K190520 | VITROS XT Chemistry Products GLU-Ca Slides | Ortho-Clinical Diagnostics, Inc. | 2019 | — |
| +1 | K040115 | Piccolo Magnesium Test System | Abaxis, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2019 | 1 | 0 |
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 JGJ? 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? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 12, 2013 | Class II | Z-0318-2014 | 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.
What does this lineage say?
- Of its descendants, K023876 (Ortho-Clinical Diagnostics, Inc., 2002) has gone furthest, with 2 descendants of its own.
How does its category compare?
All JGJ devicesJGJ Photometric Method, Magnesium: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JGJ
2in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · JGJ
Too few JGJ 510(k)s in any year since 2007 to give a median.
Recalls per year · JGJ
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JGJ
22in 2025
MAUDE reports naming product code JGJ, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 1 | — | 0 | 13 |
| 2012 | 1 | — | 1 | 22 |
| 2013 | 0 | — | 1 | 26 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 1 | 24 |
| 2016 | 0 | — | 1 | 4 |
| 2017 | 2 | — | 0 | 18 |
| 2018 | 2 | — | 0 | 21 |
| 2019 | 0 | — | 1 | 31 |
| 2020 | 0 | — | 2 | 34 |
| 2021 | 0 | — | 1 | 33 |
| 2022 | 0 | — | 1 | 42 |
| 2023 | 0 | — | 0 | 31 |
| 2024 | 0 | — | 1 | 17 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K861386 · printed Nov 5, 2026
Cite this page
510(k) Report. “K861386: Kodak Ektachem Clinical Chemistry Slides (MG).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K861386
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026