510(k) K243518— BinaxNOW COVID-19 Antigen Self Test

Substantially Equivalent

Abbott Diagnostics Scarborough, Inc.

Clearance details

Applicant: Abbott Diagnostics Scarborough, Inc.
Product code: Code QYT
Advisory panel: Microbiology
Date received: 2024-11-13
Decision date: 2025-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scarborough, ME, US

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