iHealth COVID-19 Antigen Rapid Test
K-Number: K233842 · 2024-05-31
ApplicantIhealth Labs, Inc.
Decision Date2024-05-31
Product CodeQYT
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
iHealth COVID-19 Antigen Rapid Test is a medical device manufactured by Ihealth Labs, Inc.. It received FDA 510(k) clearance on 2024-05-31 under approval number K233842. The device is classified under product code QYT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the iHealth COVID-19 Antigen Rapid Test?
iHealth COVID-19 Antigen Rapid Test is a medical device that received FDA 510(k) clearance on 2024-05-31. It is manufactured by Ihealth Labs, Inc.. The 510(k) number is K233842.
When was iHealth COVID-19 Antigen Rapid Test approved by the FDA?
iHealth COVID-19 Antigen Rapid Test received FDA 510(k) clearance on 2024-05-31, under approval number K233842.
What company makes iHealth COVID-19 Antigen Rapid Test?
iHealth COVID-19 Antigen Rapid Test is manufactured by Ihealth Labs, Inc..
What is the FDA product code for iHealth COVID-19 Antigen Rapid Test?
The FDA product code for iHealth COVID-19 Antigen Rapid Test is QYT.
Other Devices by Ihealth Labs, Inc.
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K233373Flowflex® Plus COVID-19 Home TestACON Laboratories, Inc.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.