510(k) · Cleared
ClearedMagnesium Assay (XB), Models 125-12, 125-50 and 125-S7
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Chemicals, Ltd. · JGJ Photometric Method, Magnesium
Cleared on Jan 19, 2007 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 19, 2007
- Review
- 88 days
- Class
- Class I
- Product code
- JGJ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All JGJ devicesJGJ Photometric Method, Magnesium: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Diagnostic Chemicals Limited Magnesium Assay (XB) is for the quantitative determination of magnesium in human serum. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium). This device is intended for professional use and INVITRO diagnostic use only.
The Diagnostic Chemicals Limited Magnesium Assay (XB) Standard is used for the calibration of the Diagnostic Chemicals Limited Magnesium Assay (XB) when used for the quantitative determination of magnesium in human serum.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K063208 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063208: Magnesium Assay (XB), Models 125-12, 125-50 and 125-S7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063208
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026