# K993954: Synchron Systems Dat Multi-Drug Low and High Urine Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Jan 11, 2000 after 50 days
- Product code: DKB (Calibrators, Drug Mixture)
- Device class: 2
- Regulation: 21 CFR 862.3200
- 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
- K981519: Multi-Drug Urine Diagnostic Reagents calibrators. 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 Multi-Drug Low and High Urine Calibrators, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for calibration of Amphetamines, Barbiturates, Benzodiazepine, Cocaine Metabolite, Methadone, Methaqualone, Opiate 2000 ng, Phencyclidine, and Propoxyphene enzyme immunoassays.

Source page: https://510kreport.com/device/K993954
Methodology: https://510kreport.com/methodology