# K983709: Synchron Systems Dat Low and High Urine Controls 1

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Oct 28, 1998 after 7 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K982047: MPS Huber Needle Extension Set, Medical Product Specialists (1998). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The SYNCHRON® Systems DAT Low and High Urine Controls 1, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for monitoring the quality control for Amphetamines, Cocaine Metabolite, Opiate 2000 ng, and Phencyclidine in the clinical laboratory.

Source page: https://510kreport.com/device/K983709
Methodology: https://510kreport.com/methodology