510(k) · Cleared
ClearedCarolina Liquid Chemistries CLC 6410 Chemistry Analyzer; Carolina Liquid Chemistries Glucose Reagent, Car
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carolina Liquid Chemistries Corp. · JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Cleared on May 16, 2014 after a 182-day review. The FDA summary names no predicate by number.
- Decided
- May 16, 2014
- Review
- 182 days
- Class
- Class I
- Product code
- JJE
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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 JJE? 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?
The FDA summary names no predicate by number.
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 JJE devicesJJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · JJE
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · JJE
224in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJE
6in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJE
4,400in 2025
MAUDE reports naming product code JJE, 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 | — | 20 | 2,181 |
| 2008 | 1 | — | 20 | 2,159 |
| 2009 | 0 | — | 14 | 3,440 |
| 2010 | 0 | — | 32 | 3,273 |
| 2011 | 2 | — | 25 | 11,606 |
| 2012 | 1 | — | 16 | 3,707 |
| 2013 | 1 | — | 21 | 2,489 |
| 2014 | 3 | 224 | 14 | 2,841 |
| 2015 | 0 | — | 15 | 2,793 |
| 2016 | 0 | — | 9 | 2,580 |
| 2017 | 0 | — | 18 | 1,869 |
| 2018 | 0 | — | 17 | 4,590 |
| 2019 | 1 | — | 7 | 3,948 |
| 2020 | 0 | — | 7 | 3,986 |
| 2021 | 0 | — | 6 | 3,920 |
| 2022 | 0 | — | 0 | 3,998 |
| 2023 | 0 | — | 12 | 3,783 |
| 2024 | 0 | — | 6 | 4,221 |
| 2025 | 0 | — | 6 | 4,400 |
| 2026 | 0 | — | 5 | — |
What is it indicated for?
The Carolina Liquid Chemistries CLC 6410 chemistry analyzer is an automated clinical analyzer for in vitro diagnostic use only in clinical laboratories. It is intended to be used for a variety of assay methods. The analyzer provides in vitro quantitative determinations for glucose, sodium, potassium, and chloride in serum and plasma samples. The Carolina Liquid Chemistries Glucose Reagent is for use with the Carolina Liquid Chemistries CLC 6410 Chemistry…
Read the full statement (244 words)
The Carolina Liquid Chemistries CLC 6410 chemistry analyzer is an automated clinical analyzer for in vitro diagnostic use only in clinical laboratories. It is intended to be used for a variety of assay methods. The analyzer provides in vitro quantitative determinations for glucose, sodium, potassium, and chloride in serum and plasma samples.
The Carolina Liquid Chemistries Glucose Reagent is for use with the Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer for the measurement of glucose in serum and plasma. Gluicose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and of pancreatic islet cell carcinoma.
The Carolina Liquid Chemistries ISE Kit is intended to be used with the Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer for measurement of sodium, potassium, and chloride in serum and plasma. The ISE Kit consists of ISE Buffer, internal reference solution, and reference solution. Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance. Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used for the diagnosis and treatment of electrolyte and metabolic disorders.
The Carolina Liquid Chemistries ISE Calibrator Kit consists of Calibrator 1,Calibrator 2, and Selectivity Check. It is used with the ISE Module on the Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer for the calibration of the Sodium, Potassium and Chloride assays.
For in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133519 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133519: Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer; Carolina Liquid Chemistries Glucose Reagent, Car.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133519
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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