# K972174: Lyphochek Remedi Control

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Jun 24, 1997 after 15 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 K881989 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881989: Lyphochek Urine Toxicology Control, Bio-Rad (1988) Summary page 1.

## Indications for use
Lyphochek REMEDIi Control is intended for use as a quality control urine for the REMEDIi HS Drug Profiling System.

Source page: https://510kreport.com/device/K972174
Methodology: https://510kreport.com/methodology