FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QuickVue Influenza A+B
K Number: K180288
·
Decision Feb 13, 2018
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
71
Applicant Total
37
Review Days
12
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- QuickVue Influenza A+B
- K Number
- K180288
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.3328
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Quidel Corporation
- Date Received
- February 1, 2018
- Decision Date
- February 13, 2018
- Product Code
- PSZ
- 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 |
|---|---|---|---|
| PSZ | Devices Detecting Influenza A, B, And C Virus Antigens | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PSZ), ordered by most recent decision date.
Nano-Check Influenza A+B Test
FDA 510(k)
FDA Class 2
·Microbiology
Innovita Flu A/B Antigen Rapid Test
FDA 510(k)
FDA Class 2
·Microbiology
Acucy® Influenza A&B Test with the Acucy® 2 System
FDA 510(k)
FDA Class 2
·Microbiology
BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit
FDA 510(k)
FDA Class 2
·Microbiology
BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit
FDA 510(k)
FDA Class 2
·Microbiology
Osom Ultra Plus Flu A&B Test Kit
FDA 510(k)
FDA Class 2
·Microbiology
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 |