510(k) · Cleared
ClearedEthyl Alcohol Clinical Standard Solutions
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emd Chemicals, Inc. · DLJ Calibrators, Drug Specific
Cleared on Jul 22, 1998 after a 50-day review. The FDA summary names no predicate by number.
- Decided
- Jul 22, 1998
- Review
- 50 days
- Class
- Class II
- Product code
- DLJ
- 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 DLJ? 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 DLJ devicesDLJ Calibrators, Drug Specific: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DLJ
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · DLJ
Too few DLJ 510(k)s in any year since 2007 to give a median.
Recalls per year · DLJ
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DLJ
3in 2025
MAUDE reports naming product code DLJ, 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 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 0 | — | 2 | 6 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Ethyl Alcohol Clinical Standard Solutions are intended for use in the calibration and standardization
of instruments and methods for the determination of ethyl alcohol in whole blood or serum. The Standard
Solutions may also be used for validation of the laboratory’s routine standards and/or control materials.
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/K981926 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981926: Ethyl Alcohol Clinical Standard Solutions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981926
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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