K250273

Substantially Equivalent

BinaxNOW COVID-19 Ag Card

Applicant: Abbott Diagnostics Scarborough, Inc.
Product code: QVF
Advisory panel: Microbiology
Date received: 2025-01-30
Decision date: 2025-06-13
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Scarborough, ME, US

Download summary PDF View on FDA.gov ↗

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