510(k) · Cleared
ClearedVitros Immunodiagnostics Products Free T4 Reagent Pack (Gem.1015) Free T4 Calibrators (Gem.CO15)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Clinical Diagnostics, Inc. · CEC Radioimmunoassay, Free Thyroxine
Cleared on Mar 18, 1997 after an 85-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
- Decided
- Mar 18, 1997
- Review
- 85 days
- Class
- Class II
- Product code
- CEC
- 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 CEC? 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 CEC device
- #1 K240273 Access Free T4score 7.0 · 1 generation · no Class I recall
- #2 Held for the reportin 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 CEC devicesCEC Radioimmunoassay, Free Thyroxine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CEC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CEC
238in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CEC
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEC
213in 2025
MAUDE reports naming product code CEC, 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 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 3 | 7 |
| 2011 | 0 | — | 0 | 15 |
| 2012 | 1 | — | 0 | 6 |
| 2013 | 2 | — | 1 | 6 |
| 2014 | 3 | 238 | 0 | 40 |
| 2015 | 1 | — | 0 | 166 |
| 2016 | 1 | — | 0 | 148 |
| 2017 | 1 | — | 0 | 196 |
| 2018 | 2 | — | 1 | 199 |
| 2019 | 0 | — | 0 | 167 |
| 2020 | 0 | — | 0 | 106 |
| 2021 | 0 | — | 0 | 96 |
| 2022 | 0 | — | 0 | 81 |
| 2023 | 1 | — | 0 | 99 |
| 2024 | 1 | — | 0 | 276 |
| 2025 | 0 | — | 0 | 213 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K965142 · printed Nov 6, 2026
Cite this page
510(k) Report. “K965142: Vitros Immunodiagnostics Products Free T4 Reagent Pack (Gem.1015) Free T4 Calibrators (Gem.CO15).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K965142
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026