# K974002: Ethanol-SL Assay, Catalogue Number 240-12

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Chemicals, Ltd.
- Decided: Apr 1, 1998 after 162 days
- Product code: DIC (Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method)
- Device class: 2
- Regulation: 21 CFR 862.3040
- 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
For the quantitative determination of ethanol in serum, plasma or urine. For IN VITRO diagnostic use.

Source page: https://510kreport.com/device/K974002
Methodology: https://510kreport.com/methodology