# K973054: Ethyl Alcohol Clinical Standard Solutions

- Pathway: 510(k) (Traditional)
- Applicant: Emd Chemicals, Inc.
- Decided: Oct 1, 1997 after 47 days
- Product code: DNN (Calibrators, Ethyl Alcohol)
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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/K973054
Methodology: https://510kreport.com/methodology