# K942640: Dupont Dimension Amylase Method

- Pathway: 510(k) (Traditional)
- Applicant: Dupont Medical Products
- Decided: Sep 9, 1994 after 98 days
- Product code: JFJ (Catalytic Methods, Amylase)
- Device class: 2
- Regulation: 21 CFR 862.1070
- Recalls of this device: none
- 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; 1 cites 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K061655: Dimension Vista Flex Reagent Cartridges (2006), 1 descendant of its own
- K140790: Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG) (2015), 0 descendants of its own

Source page: https://510kreport.com/device/K942640
Methodology: https://510kreport.com/methodology