# K993022: Synchron Systems OP 300 Low and High Urine Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Nov 9, 1999 after 61 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: 1 generation back to K983747 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983747: Synchron Systems Dat Low and High Urine Calibrators II, Beckman Coulter, Inc. (1998) Summary page 1.

## Indications for use
The Beckman Coulter OP 300 Low and High Urine Calibrators, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for the calibration of Opiate 300 ng (Part No. 475024) enzyme immunoassays.

Source page: https://510kreport.com/device/K993022
Methodology: https://510kreport.com/methodology