# K000331: Synchron LX Systems Microalbumin Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Feb 10, 2000 after 50 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K142346: Urine/CSF Albumin, Urine/CSF Albumin Calibrator (2014), 0 descendants of its own

Source page: https://510kreport.com/device/K000331
Methodology: https://510kreport.com/methodology