# K933180: Quanta Lite Mitochondria M2 Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Aug 5, 1993 after 36 days
- Product code: DGC (Ige, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5510
- 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
- K031308: Rhigene Mesacup-2 Anti-Mitochondria M2 Test, Model 10760 (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K933180
Methodology: https://510kreport.com/methodology