# K123321: Dimension Chemistry Iii Calibratory

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Feb 15, 2013 after 112 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
Longest line of descent: 1 generation back to K062334 (2006). 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)
- K062334: Dimension Vista Chemistry 3 Calibrator, Model KC130, Dade Behring, Inc. (2006) Summary page 1.

## Indications for use
The CHEM III CAL is an in vitro diagnostic product for the calibration of Ammonia (AMM), Carbon Dioxide (CO2) and Ethyl Alcohol (ETOH) methods on the Dimensions clinical chemistry system.

Source page: https://510kreport.com/device/K123321
Methodology: https://510kreport.com/methodology