# K830206: TDX N-Acetylprocainamide

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Feb 18, 1983 after 28 days
- Product code: LAN (Enzyme Immunoassay, N-Acetylprocainamide)
- 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; 2 cite 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
- K962269: Cedia Cardiac TDM Multi-Cals (1996), 1 descendant of its own
- K972433: Cedia Digoxin Calibrators (1997), 0 descendants of its own
- K963306: Cedia N-Acetylprocainamide Assay (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K830206
Methodology: https://510kreport.com/methodology