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..
Clearance details
- Applicant
- Ihealth Labs, Inc.
- Product code
- Code QYT
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.