510(k) K251092— iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro

Substantially Equivalent

Ihealth Labs, Inc.

Clearance details

Applicant: Ihealth Labs, Inc.
Product code: Code SCA
Advisory panel: Microbiology
Date received: 2025-04-10
Decision date: 2025-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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