FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CareSuperb COVID-19 Antigen Home Test
K Number: K241915
·
Decision Jan 29, 2025
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
13
Applicant Total
3
Review Days
212
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Basic Information
- Device Name
- CareSuperb COVID-19 Antigen Home Test
- K Number
- K241915
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3984
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Access Bio, Inc.
- Date Received
- July 1, 2024
- Decision Date
- January 29, 2025
- Product Code
- QYT
- 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 |
|---|---|---|---|
| QYT | Over-The-Counter Covid-19 Antigen Test | FDA class 2 | Microbiology |
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