# K123198: Liquichek Ethanol/Ammonia Control Level 1 Model 271, Liquichek Ethanol/Ammonia Control Level 2 Model 272, Liquichek Etha

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories
- Decided: Nov 20, 2012 after 40 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K955024 (1995). 1 ancestor in all.
1 later device descends 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)
- K955024: Liquichek Ethanol/Ammonia Control, Bio-Rad (1995) Summary page 1.

## Most influential descendants
- K140393: Randox Ammonia Ethanol Control Levels 1, 2 and Level 3 (2014), 0 descendants of its own

## Indications for use
Liquichek Ethanol/Ammonia Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. The following analytes are included in the package insert: 1. Ethanol 2. Ammonia

Source page: https://510kreport.com/device/K123198
Methodology: https://510kreport.com/methodology