FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Sofia RSV FIA on Sofia 2 analyzer
K Number: K162911
·
Decision Feb 22, 2017
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
31
Applicant Total
37
Review Days
128
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Basic Information
- Device Name
- Sofia RSV FIA on Sofia 2 analyzer
- K Number
- K162911
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3480
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Quidel Corporation
- Date Received
- October 17, 2016
- Decision Date
- February 22, 2017
- Product Code
- GQG
- 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 |
|---|---|---|---|
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | FDA class 1 | Microbiology |
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Other Clearances by Quidel Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K231795 | QuickVue COVID-19 Test | Mar 22, 2024 | Substantially Equivalent |
| K232286 | Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument | Dec 20, 2023 | Substantially Equivalent |
| K233688 | Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set | Dec 13, 2023 | Substantially Equivalent |
| 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 |