FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Variola virus Real-Time PCR Assay
K Number: DEN160016
·
Decision Feb 6, 2017
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
6
Review Days
298
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Basic Information
- Device Name
- Variola virus Real-Time PCR Assay
- K Number
- DEN160016
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 866.3316
- Medical Specialty
- Microbiology
- Decision
- Unknown
- Applicant
- Centers For Disease Control and Prevention (CDC)
- Date Received
- April 14, 2016
- Decision Date
- February 6, 2017
- Product Code
- PRA
- 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 |
|---|---|---|---|
| PRA | Variola Virus Nucleic Acid-Based Detection Assay | 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 |
| K161556 | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit | Jun 30, 2016 | Substantially Equivalent |
| K153148 | CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping | Dec 1, 2015 | Substantially Equivalent |
| K140426 | ANTHRACIS REAL-TIME PCR ASSAY | May 22, 2014 | Substantially Equivalent |