Class Class II

iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro (K251085)

K251085 2025-12-12 Traditional
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Description

iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro by Ihealth Labs, Inc., an FDA 510(k) cleared microbiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251085
Clearance Date2025-12-12
Clearance TypeTraditional
Product CodeSCA
Regulation Number866.3987

Categories

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