CareSuperb COVID-19 Antigen Home Test— 510(k) K241915
Substantially EquivalentAccess Bio, Inc.
FDA 510(k) clearance K241915 for CareSuperb COVID-19 Antigen Home Test, Substantially Equivalent on 2025-01-29. Applicant: Access Bio, Inc..
Clearance details
- Applicant
- Access Bio, Inc.
- Product code
- Code QYT
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Somerset, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.