# K882117: Ethyl Alcohol Standard

- Pathway: 510(k) (Traditional)
- Applicant: Verichem Laboratories, Inc.
- Decided: Aug 4, 1988 after 77 days
- Product code: DNN (Calibrators, Ethyl Alcohol)
- Device class: 2
- Regulation: 21 CFR 862.3200
- Recalls of this device: 3 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Sep 20, 2006 · Not classified · Z-0744-2007: Potential for microorganism growth in the alcohol standard.
- Jun 9, 2006 · Not classified · Z-1545-06: Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial st
- Jun 9, 2006 · Not classified · Z-1549-06: Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial st

Source page: https://510kreport.com/device/K882117
Methodology: https://510kreport.com/methodology