FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping
K Number: K153148
·
Decision Dec 1, 2015
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
19
Applicant Total
6
Review Days
32
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Basic Information
- Device Name
- CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping
- K Number
- K153148
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.3980
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Centers For Disease Control and Prevention (CDC)
- Date Received
- October 30, 2015
- Decision Date
- December 1, 2015
- Product Code
- OZE
- 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 |
|---|---|---|---|
| OZE | Influenza A And Influenza B Multiplex Nucleic Acid Assay | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OZE), ordered by most recent decision date.
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)
FDA 510(k)
FDA Class 2
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CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)
FDA 510(k)
FDA Class 2
·Microbiology
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)
FDA 510(k)
FDA Class 2
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Lyra Influenza A+B Assay
FDA 510(k)
FDA Class 2
·Microbiology
ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2
FDA 510(k)
FDA Class 2
·Microbiology
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by Centers For Disease Control and Prevention (CDC)
| K Number | Device Name | ||
|---|---|---|---|
| K181736 | CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit, | Jul 30, 2018 | Substantially Equivalent |
| K170940 | Rickettsia Real-time PCR Assay | Jun 29, 2017 | Substantially Equivalent |
| DEN160016 | Variola virus Real-Time PCR Assay | Feb 6, 2017 | Unknown |
| K161556 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit | Jun 30, 2016 | Substantially Equivalent |
| K140426 | ANTHRACIS REAL-TIME PCR ASSAY | May 22, 2014 | Substantially Equivalent |