# K163359: ARK Methotrexate Assay

- Pathway: 510(k) (Special)
- Applicant: Ark Diagnostics, Inc.
- Decided: Aug 18, 2017 after 261 days
- Product code: LAO (Enzyme Immunoassay, Methotrexate)
- Device class: U
- Recalls of this device: none
- 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. The FDA summary names no predicate by number.

Source page: https://510kreport.com/device/K163359
Methodology: https://510kreport.com/methodology