# K950138: Drugs of Abuse Controls

- Pathway: 510(k) (Traditional)
- Applicant: E.I. Dupont DE Nemours & Co., Inc.
- Decided: Feb 22, 1995 after 40 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
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
- K062191: Dimension Vista System Drugs of Abuse Positive and Negative Controls, Models KC515 and KC516 (2006), 0 descendants of its own

Source page: https://510kreport.com/device/K950138
Methodology: https://510kreport.com/methodology