# K983747: Synchron Systems Dat Low and High Urine Calibrators II

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Dec 30, 1998 after 68 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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
- K985101: Drugs of Abuse Urine Calibrators II. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K993023: Synchron Systems OP 300 Low and High Urine Controls (1999), 0 descendants of its own
- K993022: Synchron Systems OP 300 Low and High Urine Calibrators (1999), 0 descendants of its own

## Indications for use
The SYNCHRON® Systems DAT Low and High Urine Calibrators Ii, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for the calibrations of Barbiturates, Benzodiazepine, Methadone, Opiate 300 ng, Methaqualone, and Propoxyphene enzyme immunoassays.

Source page: https://510kreport.com/device/K983747
Methodology: https://510kreport.com/methodology