# K965157: Cedia Dau Multi-Drug Control Cedia Dau Specialty Control Set 1

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jan 17, 1997 after 25 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 K935062 (1994). 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)
- K935062: Mas Liquid Urinalysis Control, Medical Analysis Systems, Inc. (1994) Summary page 1.
- K951135: Multi-Drug Control Set, Microgenics Corp. (1995) Summary page 1.

## Indications for use
The modified Multi-Drug Control Set and the modified Specialty Control Set 1 are intended to be used as quality control material to monitor drugs of abuse assays.

Source page: https://510kreport.com/device/K965157
Methodology: https://510kreport.com/methodology