CareSuperb COVID-19/Flu A&B Antigen Combo Home Test— 510(k) K251604
Substantially EquivalentAccess Bio, Inc.
FDA 510(k) clearance K251604 for CareSuperb COVID-19/Flu A&B Antigen Combo Home Test, Substantially Equivalent on 2025-08-22. Applicant: Access Bio, Inc.. Device class: 2.
Clearance details
- Applicant
- Access Bio, Inc.
- Product code
- Code SCA
- Device class
- Class 2
- Regulation
- 21 CFR 866.3987
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Monroe Township, NJ, US
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More clearances from Access Bio, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.