# K833384: Procainamide Analytical Test Pack

- Pathway: 510(k) (Traditional)
- Applicant: E.I. Dupont DE Nemours & Co., Inc.
- Decided: Dec 27, 1983 after 89 days
- Product code: LAR (Enzyme Immunoassay, Procainamide)
- Device class: 2
- Regulation: 21 CFR 862.3320
- 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
- K032573: Dimension Procainamide (Proc) Flex Reagent Cartridge Method, Model DF110 (2003), 2 descendants of its own
- 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/K833384
Methodology: https://510kreport.com/methodology