# K062122: Dimension Vista System Chemistry 3 Calibrator (Chem 3 Cal - KC130)

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Aug 25, 2006 after 31 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Dimension Chemistry 3 Calibrator: named in the summary without a submission number

## Indications for use
The CHEM 3 CAL is an in vitro diagnostic product for the calibration of alcohol (ALC), and carbon dioxide (CO2) methods on the Dimension Vista' System.

Source page: https://510kreport.com/device/K062122
Methodology: https://510kreport.com/methodology