FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QuickVue COVID-19 Test
K Number: K231795
·
Decision Mar 22, 2024
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
13
Applicant Total
37
Review Days
276
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Basic Information
- Device Name
- QuickVue COVID-19 Test
- K Number
- K231795
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3984
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Quidel Corporation
- Date Received
- June 20, 2023
- Decision Date
- March 22, 2024
- 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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|---|---|---|---|
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| K230349 | Lyra RSV+hMPV Assay | Mar 10, 2023 | Substantially Equivalent |
| DEN220039 | Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set | Mar 8, 2023 | Unknown |
| K230236 | Lyra Influenza A+B Assay | Mar 3, 2023 | Substantially Equivalent |
| K211342 | Sofia 2 Campylobacter FIA | Nov 23, 2021 | Substantially Equivalent |
| K173496 | Sofia 2 Lyme FIA, Sofia Lyme Control Set | Aug 30, 2018 | Substantially Equivalent |
| K181029 | Solana Bordetella Complete Assay | Jul 15, 2018 | Substantially Equivalent |
| K173691 | Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack | Feb 28, 2018 | Substantially Equivalent |
| K180288 | QuickVue Influenza A+B | Feb 13, 2018 | Substantially Equivalent |