510(k) · Cleared
ClearedOlympus Calcium Arsenazo Iii Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Diagnostica GmbH · CJY Azo Dye, Calcium
Cleared on Jun 24, 1998 after a 14-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jun 24, 1998
- Review
- 14 days
- Class
- Class II
- Product code
- CJY
- 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 CJY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CJY device
- #1 K244042 Calcium2score 9.4 · 3 generations · no Class I recall
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 CJY devicesCJY Azo Dye, Calcium: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CJY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CJY
Too few CJY 510(k)s in any year since 2007 to give a median.
Recalls per year · CJY
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CJY
59in 2025
MAUDE reports naming product code CJY, 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 | 2 | — | 0 | 3 |
| 2008 | 2 | — | 0 | 4 |
| 2009 | 1 | — | 0 | 8 |
| 2010 | 0 | — | 0 | 10 |
| 2011 | 0 | — | 0 | 9 |
| 2012 | 1 | — | 0 | 5 |
| 2013 | 1 | — | 4 | 8 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 26 |
| 2018 | 1 | — | 2 | 21 |
| 2019 | 1 | — | 0 | 29 |
| 2020 | 0 | — | 0 | 33 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 1 | 17 |
| 2023 | 0 | — | 0 | 29 |
| 2024 | 0 | — | 0 | 34 |
| 2025 | 1 | — | 0 | 59 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Olympus Calcium Arsenazo Reagent is intended for the quantitative determination of Calcium concentrations in human serum on Olympus clinical chemistry analyzers.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982035 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982035: Olympus Calcium Arsenazo Iii Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982035
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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