# K971691: Liquichek Urine Toxicology Control - Level S1, S2, S3

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: May 30, 1997 after 23 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: 1 generation back to K903430 (1990). 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)
- K903430: Liquichek CK/LD Isoenzyme Control; Levels 1 and 2, Bio-Rad (1990) Summary page 1.

## Most influential descendants
- K992395: Urine Drug Screening Control (1999), 0 descendants of its own

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

Source page: https://510kreport.com/device/K971691
Methodology: https://510kreport.com/methodology