# K891691: Lyphochek Urine Metals Control, Levels I and II

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Dec 19, 1989 after 272 days
- Product code: DIE (Heavy Metals 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K990928: Lyphocheck Urine Metals Control, Item NO.400, 405 (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K891691
Methodology: https://510kreport.com/methodology