# K801204: Emit Disopyramide Assay

- Pathway: 510(k) (Traditional)
- Applicant: Syva Co.
- Decided: Jun 9, 1980 after 21 days
- Product code: KLR (Enzyme Immunoassay, Lidocaine)
- Device class: 2
- Regulation: 21 CFR 862.3555
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Jun 26, 2026 · Class III · Z-2880-2026: Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk to lab technicians du

Source page: https://510kreport.com/device/K801204
Methodology: https://510kreport.com/methodology