# K062334: Dimension Vista Chemistry 3 Calibrator, Model KC130

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Sep 22, 2006 after 43 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K123677: Dimension Vista; Ammonia Flex Reagent Cartridge (Amm), Chemistry 3 Calibrator (Chem 3 Cal) (2013), 0 descendants of its own
- K123321: Dimension Chemistry Iii Calibratory (2013), 0 descendants of its own

## Recalls of this device
- Oct 23, 2009 · Not classified · Z-1535-2010: patient results are depressed

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

Source page: https://510kreport.com/device/K062334
Methodology: https://510kreport.com/methodology