510(k) · Cleared
ClearedVitros Immunodiagnostics Products T3 Uptake Reagent Pack (Gem.1025) and T3 Uptake Calibrators (Gem.C025)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Clinical Diagnostics, Inc. · KHQ Radioassay, Triiodothyronine Uptake
Cleared on Nov 27, 1996 after a 29-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
- Decided
- Nov 27, 1996
- Review
- 29 days
- Class
- Class II
- Product code
- KHQ
- Recalls
- None
- Predicates
- 0
FDA lists a 510(k) statement for it but has not posted the file, 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 KHQ? 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 lists a 510(k) statement for it but has not posted the file, 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All KHQ devicesKHQ Radioassay, Triiodothyronine Uptake: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KHQ
FDA has decided no KHQ device since 2007.
Median 510(k) review, days · KHQ
Too few KHQ 510(k)s in any year since 2007 to give a median.
Recalls per year · KHQ
No recall names KHQ since 2007.
Adverse event reports per year · KHQ
1in 2021
MAUDE reports naming product code KHQ, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K964308 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964308: Vitros Immunodiagnostics Products T3 Uptake Reagent Pack (Gem.1025) and T3 Uptake Calibrators (Gem.C025).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964308
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026