iHealth COVID-19 Antigen Rapid Test— 510(k) K233842
Substantially EquivalentIhealth Labs, Inc.
FDA 510(k) clearance K233842 for iHealth COVID-19 Antigen Rapid Test, Substantially Equivalent on 2024-05-31. Applicant: Ihealth Labs, Inc.. Device class: 2.
Clearance details
- Applicant
- Ihealth Labs, Inc.
- Product code
- Code QYT
- Device class
- Class 2
- Regulation
- 21 CFR 866.3984
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code QYT
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