# K994325: Synchron CX Systems Microalbumin Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Jan 12, 2000 after 21 days
- Product code: JIS (Calibrator, Primary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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 K895883 (1989). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973928: Beckman Urine Protein Calibrator (Ucal), Beckman Instruments, Inc. (1997) Summary page 1.

## Indications for use
MA Calibrator, when used in conjunction with SYNCHRON Systems MA Reagent (P/N 475100), is intended for use on the SYNCHRON CX Systems for the calibration of Microalbumin.

Source page: https://510kreport.com/device/K994325
Methodology: https://510kreport.com/methodology