# K993473: Synchron Systems Drug Calibrator 2

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Nov 26, 1999 after 43 days
- Product code: DLJ (Calibrators, Drug Specific)
- 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
Longest line of descent: 2 generations back to K882233 (1988). 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)
- K982935: Synchron Systems Digoxin (Dign) Reagent, Synchron Systems Drug Calibrator, Beckman Coulter, Inc. (1998) Summary page 1.

## Indications for use
The Beckman Coulter Drug Calibrator 2 is a six-level calibrator intended for use on the SYNCHRON CX Systems and LX20 Systems for the calibration of digoxin and acetaminophen.

Source page: https://510kreport.com/device/K993473
Methodology: https://510kreport.com/methodology