# K983640: Synchron Systems Lipid Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Dec 21, 1998 after 66 days
- Product code: JIS (Calibrator, Primary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K936184 (1994). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974452: Vigil Lipid Control, Beckman Instruments, Inc. (1997) Summary page 1.

## Most influential descendants
- K042195: Synchron Systems HDL Cholesterol (HDL), Synchron Systems Lipid Plus Calibrators 1 & 2, Models A15625/A16747 (2004), 0 descendants of its own

## Recalls of this device
- Oct 3, 2003 · Not classified · Z-1153-04: Incorrect units are printed in labeling but not in software.

## Indications for use
The SYNCHRON® Systems Lipid Calibrator, used in conjunction with SYNCHRON® HDL Cholesterol reagent, is intended for use on Beckman’s SYNCHRON Systems for the calibration of HDL Cholesterol test systems.

Source page: https://510kreport.com/device/K983640
Methodology: https://510kreport.com/methodology