# K083850: Euroimmun Anca Ifa Europlus Granulocyte Biochip Mosaic Test Systems

- Pathway: 510(k) (Traditional)
- Applicant: Euroimmun Us, Inc.
- Decided: May 20, 2009 after 147 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K100017: Euroimmun Hippocampus/Cerebellum/Glutamate Receptor/Ifa Biochip Mosaic Test System (2010), 0 descendants of its own

Source page: https://510kreport.com/device/K083850
Methodology: https://510kreport.com/methodology