FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CareSuperb COVID-19/Flu A&B Antigen Combo Home Test
K Number: K251604
·
Decision Aug 22, 2025
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
10
Applicant Total
3
Review Days
87
Basic Information
- Device Name
- CareSuperb COVID-19/Flu A&B Antigen Combo Home Test
- K Number
- K251604
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3987
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Access Bio, Inc.
- Date Received
- May 27, 2025
- Decision Date
- August 22, 2025
- Product Code
- SCA
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| SCA | Multi-Analyte Respiratory Virus Antigen Detection Test | FDA class 2 | Microbiology |
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