# K981926: Ethyl Alcohol Clinical Standard Solutions

- Pathway: 510(k) (Traditional)
- Applicant: Emd Chemicals, Inc.
- Decided: Jul 22, 1998 after 50 days
- Product code: DLJ (Calibrators, Drug Specific)
- Device class: 2
- Regulation: 21 CFR 862.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
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.

Source page: https://510kreport.com/device/K981926
Methodology: https://510kreport.com/methodology