510(k) · Cleared
ClearedParamax Ammonia and Ammonia Blank Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Intl., Inc. · JIF Enzymatic Method, Ammonia
Cleared on Nov 22, 1996 as substantially equivalent to K770363 (E.I. Dupont DE Nemours & Co., Inc., 1977) after an 8-day review. Its family tree reaches back 1 generation to 1977.
- Decided
- Nov 22, 1996
- Review
- 8 days
- Class
- Class I
- Product code
- JIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K770363 (1977). No later device cites it as a predicate yet.
- Root · 1 generation backK770363 Aca Ammonia Analytical Test PackE.I. Dupont DE Nemours & Co., Inc. · 1977
- This deviceK964565 Paramax Ammonia and Ammonia Blank ReagentDade Intl., Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K770363 | Aca Ammonia Analytical Test Pack | E.I. Dupont DE Nemours & Co., Inc. | 1977 | — |
| 0 (this device) | K964565 | Paramax Ammonia and Ammonia Blank Reagent | Dade Intl., Inc. | 1996 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JIF? 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K770363 | Aca Ammonia Analytical Test PackSummary page 1…ry of Safety and Effectiveness Information The Paramax® Ammonia and Ammonia Blank Reagent is substantially equivalent to its predecessor, which was cleared to market on K770363. The proposed and the predicate device are intended for use as quantitative determination of Ammonia and Ammonia Blank in plasma.… | 1977 |
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.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K770363.
How does its category compare?
All JIF devicesJIF Enzymatic Method, Ammonia: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIF
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · JIF
Too few JIF 510(k)s in any year since 2007 to give a median.
Recalls per year · JIF
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIF
5in 2025
MAUDE reports naming product code JIF, 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 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 1 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 7 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 1 | 3 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The proposed and the predicate device are intended for use as quantitative determination of Ammonia and Ammonia Blank in plasma.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964565 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964565: Paramax Ammonia and Ammonia Blank Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964565
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026