# K010960: Emit II Plus Ethyl Alcohol Assay, Model OSR9K229

- Pathway: 510(k) (Special)
- Applicant: Syva Co., Dade Behring, Inc.
- Decided: Apr 26, 2001 after 27 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; 2 cite 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
- K071811: Etoh Flex Reagent Cartridge (DF22) (2007), 0 descendants of its own
- K070853: Dimension Vista Etoh Flex Reagent Cartridge, Model K5022 (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K010960
Methodology: https://510kreport.com/methodology