# Binx Health, Inc.

- Location (FDA's records): Boston, MA
- FDA decisions: 2 (2019–2020): 2 510(k) clearances
- Product codes: QEP (2)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Becton, Dickinson & CO: 2 (https://510kreport.com/company/becton-dickinson)

## Its most-cited devices
- K191352: binx health io CT/NG Assay (2019), cited by 1

## Recent decisions
- K200533: binx io CT/NG Assay and binx io CT/NG System (Apr 27, 2020)
- K191352: binx health io CT/NG Assay (Aug 8, 2019)

Source page: https://510kreport.com/company/binx-health