FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Lyra RSV+hMPV Assay
K Number: K230349
·
Decision Mar 10, 2023
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
5
Applicant Total
37
Review Days
29
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Basic Information
- Device Name
- Lyra RSV+hMPV Assay
- K Number
- K230349
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.3980
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Quidel Corporation
- Date Received
- February 9, 2023
- Decision Date
- March 10, 2023
- Product Code
- OEM
- 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 |
|---|---|---|---|
| OEM | Human Metapneumovirus (Hmpv) Rna Assay System | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OEM), ordered by most recent decision date.
PRO HMPV+ ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
QUIDEL MOLECULAR RSV + HMPV ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
PRO HMPV+ ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
QUIDEL MOLECULAR HMPV ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
PRO HMPV+ ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by Quidel Corporation
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |