# K864230: Dimension (TM) Clinical Chemistry System

- Pathway: 510(k) (Traditional)
- Applicant: E.I. Dupont DE Nemours & Co., Inc.
- Decided: Nov 28, 1986 after 31 days
- Product code: CKE (Acid Phosphatase, Thymolphthale Inmonophosphate)
- Device class: 2
- Regulation: 21 CFR 862.1020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K994115: Total Iron Binding Capacity (Ibct) Flex Reagent Cartridge (2000), 2 descendants of its own
- K061020: Dimension Vista Albumin, Alkaline Phosphatase, Aspartate Amino Transferase, Carbamazepine & Alanine Amino Transferase (2006), 0 descendants of its own
- K052867: Vitros Chemistry Products Dtibc Reagent (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K864230
Methodology: https://510kreport.com/methodology