# K120504: Liquichek Urine Toxicology Control, S10 & S10 Minipak, Liquichek Urine Toxicology Control, Level S20 & Level S20 Minipak

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Mar 27, 2012 after 35 days
- Product code: DIF (Drug Mixture Control Materials)
- Device class: 1
- Regulation: 21 CFR 862.3280
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K021411 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033924: Liquichek Urine Toxicology Control (Screen Series), Bio-Rad Laboratories, Inc. (2004) Summary page 1.

## Indications for use
Liquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the precision of laboratory urine toxicology screening procedures.

Source page: https://510kreport.com/device/K120504
Methodology: https://510kreport.com/methodology