FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument
K Number: K232286
·
Decision Dec 20, 2023
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
8
Applicant Total
37
Review Days
141
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Basic Information
- Device Name
- Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument
- K Number
- K232286
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3309
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Quidel Corporation
- Date Received
- August 1, 2023
- Decision Date
- December 20, 2023
- Product Code
- PGI
- 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 |
|---|---|---|---|
| PGI | Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples | FDA class 2 | Microbiology |
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FDA 510(k)
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Other Clearances by Quidel Corporation
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|---|---|---|---|
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| 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 |