# Magellan Diagnostics

- Location (FDA's records): N. Billerica, MA
- FDA decisions: 2 (2013–2015): 2 510(k) clearances
- Product codes: DOF (2)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 6 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Esa Biosciences, Inc.: 1 (https://510kreport.com/company/esa-biosciences)

## Its most-cited devices
- K123563: Leadcare (R)  Ultra (TM) Blood Lead Testing System (2013), cited by 1

## Recent decisions
- K142705: LeadCare Plus Blood Lead Testing System (Jul 7, 2015)
- K123563: Leadcare (R)  Ultra (TM) Blood Lead Testing System (Aug 20, 2013)

Source page: https://510kreport.com/company/magellan-diagnostics