510(k) K251595— COVID-19 Detect Rapid Self -Test

Substantially Equivalent

InBios International, Inc.

Clearance details

Applicant: InBios International, Inc.
Product code: Code QYT
Advisory panel: Microbiology
Date received: 2025-05-27
Decision date: 2025-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

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