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Ihealth Labs, Inc.

FDA 510(k) & PMA Approved Devices — 4 products

Total Devices4
Categories3
Latest FDA decision2025-12-12
TypeNumberDevice NameCodeDateActions
510(k) K251092 iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test ProSCA2025-12-12 View
510(k) K251085 iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test ProSCA2025-12-12 View
510(k) K243146 iCare APPMWI2025-02-03 View
510(k) K233842 iHealth COVID-19 Antigen Rapid TestQYT2024-05-31 View
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