# K923783: Ethyl Alcohol Assay

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Reagents, Inc.
- Decided: Jan 21, 1993 after 177 days
- Product code: DMT (Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet)
- 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K032461: Ethyl Alcohol Enzymatic Assay, Catalog #0220 & 0221 (2003), 1 descendant of its own
- K181553: Immunalysis Ethyl Alcohol Enzyme Assay (2018), 0 descendants of its own
- K971506: Synchron Systems Alcohol (Alc) Reagent, Synchron Systems Alcohol Calibrator (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K923783
Methodology: https://510kreport.com/methodology