# K903153: Emit Ethyl Alcohol Assay

- Pathway: 510(k) (Traditional)
- Applicant: Syva Co.
- Decided: Aug 9, 1990 after 22 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K993980: Syva Emit II Plus Ethyl Alcohol Assay, Models 9K309UL/9K409UL (2000), 1 descendant of its own
- K013538: Ethanol (2001), 0 descendants of its own

Source page: https://510kreport.com/device/K903153
Methodology: https://510kreport.com/methodology