# K944093: Dimension (R) XL Clinical Chemistry System

- Pathway: 510(k) (Traditional)
- Applicant: E.I. Dupont DE Nemours & Co., Inc.
- Decided: Nov 10, 1994 after 80 days
- Product code: JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K051087: Dimension Vista Integrated System (2005), 5 descendants of its own
- K073561: Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator (2008), 1 descendant of its own
- K061838: Dimension Vista Chemistry 1 Calibrator, Model KC110 (2006), 1 descendant of its own
- K060266: Dimension Iron Calibrator (2006), 1 descendant of its own
- K060264: Dimension Iron Flex Reagent Cartridge (Iron-DF85) (2006), 1 descendant of its own

Source page: https://510kreport.com/device/K944093
Methodology: https://510kreport.com/methodology