# K172461: AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin

- Pathway: 510(k) (Traditional)
- Applicant: Aesku.Diagnostics GmbH & Co. KG
- Decided: Mar 23, 2018 after 221 days
- Product code: MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca))
- Device class: 2
- Regulation: 21 CFR 866.5660
- 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/K172461
Methodology: https://510kreport.com/methodology