iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro

• K Number: K251092
• Device Name: iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro
• Manufacturer: Ihealth Labs, Inc.
• Date Cleared: 2025-12-12 ( 246 days)
• Product Code: SCA
• Regulation Number: 866.3987
• Type: Traditional
• Panel: Microbiology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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Device Description

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AI/ML Overview

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Summary

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Regulation Number and Section

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