K243489

Substantially Equivalent

Alinity m EBV (09N43-095)

Applicant: Abbott Molecular, Inc.
Product code: QLX
Advisory panel: Microbiology
Date received: 2024-11-12
Decision date: 2025-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Plaines, IL, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.