# K993023: Synchron Systems OP 300 Low and High Urine Controls

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Nov 26, 1999 after 78 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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). Our OCR of the scanned summary read K983748, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SYNCHRON Systems DAT Low and High Urine Controls”.

## Indications for use
The Beckman Coulter OP 300 Low and High Urine Controls, in conjunction with SYNCHRON Reagents, are intended for use on SYNCHRON Systems for monitoring the quality control for Opiate 300 ng in the clinical laboratory.

Source page: https://510kreport.com/device/K993023
Methodology: https://510kreport.com/methodology