# K934965: Binax Legionella Urinary Antigen Eia

- Pathway: 510(k) (Traditional)
- Applicant: Binax, Inc.
- Decided: Sep 20, 1994 after 340 days
- Product code: MJH (Legionella, Spp., Elisa)
- Device class: 2
- Regulation: 21 CFR 866.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 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
- K982238: Binax Now Legionella Urinary Antigen Test Model 852-020 and Binax Now Leg Ionella Urinary Antigen Control Kit Model 8522 (1998), 3 descendants of its own
- K070522: Modification to: Binax Now  Legionella Urinary Antigen Test, #852-000,852-012 (2007), 1 descendant of its own
- K191184: ImmuView S pneumoniae and L pneumophila Urinary Antigen Test (2020), 0 descendants of its own
- K113190: Tru Legionella (2012), 0 descendants of its own

Source page: https://510kreport.com/device/K934965
Methodology: https://510kreport.com/methodology