# Biohelix Corporation

- Location (FDA's records): Beverly, MA
- FDA decisions: 1 (2011–2011): 1 510(k) clearance
- Product codes: OQO (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Eragen Biosciences: 1 (https://510kreport.com/company/eragen-biosciences)

## Firms that cite its devices most
- Quidel Corp.: 1 (https://510kreport.com/company/quidel)

## Its most-cited devices
- K111951: Isoamp HSV Assay (2011), cited by 1

## Recent decisions
- K111951: Isoamp HSV Assay (Sep 27, 2011)

Source page: https://510kreport.com/company/biohelix