# K863840: Meth. & Cali. for the Dimension Clini/Chem. System

- Pathway: 510(k) (Traditional)
- Applicant: E.I. Dupont DE Nemours & Co., Inc.
- Decided: Nov 5, 1986 after 35 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.
7 later devices descend from it; 5 cite it directly.
0 of 8 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
- K994114: Dimension Total Iron Binding Capacity (Ibct) Calibrator (2000), 2 descendants of its own
- K123677: Dimension Vista; Ammonia Flex Reagent Cartridge (Amm), Chemistry 3 Calibrator (Chem 3 Cal) (2013), 0 descendants of its own
- K123320: Dimension Ammonia Flex Reagent Cartridge (2013), 0 descendants of its own
- K062316: Dimension Vista Ammonia (Amon) Flex Reagent Cartridge (2006), 0 descendants of its own
- K062152: Creatinine Kinase MB Isoenzyme Verifier, Model DC27 (2006), 0 descendants of its own

Source page: https://510kreport.com/device/K863840
Methodology: https://510kreport.com/methodology