# K871645: TDXR Rea (TM) Ethanol

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jun 11, 1987 after 44 days
- Product code: DIC (Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method)
- Device class: 2
- Regulation: 21 CFR 862.3040
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K972011: Opus Ethanol (1997), 0 descendants of its own

## Recalls of this device
- Dec 5, 2003 · Not classified · Z-0508-04: The reagent package inserts for the products contain incorrect information in the Specific Performance Characteristics section. Accuracy by Correlation table
- Nov 17, 2003 · Not classified · Z-0278-04: The package inserts contain incorrect values for the alternate unit (mol/L) Control Ranges

Source page: https://510kreport.com/device/K871645
Methodology: https://510kreport.com/methodology