# K020723: Dimension Aldl Calibrator, Model DC131

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: May 8, 2002 after 63 days
- Product code: JIT (Calibrator, Secondary)
- 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: 1 generation back to K983850 (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)
- K983850: Dimension Ahdl Calibrator, Dade Behring, Inc. (1998) Summary page 1.

## Indications for use
The Dade Behring Dimension® ALDL Calibrator is an in vitro diagnostic device intended for use on Dade Behring Dimension® clinical chemistry systems for medical purposes to establish points of reference that are used in determination of low density lipoprotein cholesterol in human serum and plasma

Source page: https://510kreport.com/device/K020723
Methodology: https://510kreport.com/methodology