FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch
K Number: K160462
·
Decision Mar 17, 2016
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
3
Applicant Total
28
Review Days
27
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Basic Information
- Device Name
- FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch
- K Number
- K160462
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 866.3970
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biofire Diagnostics, LLC
- Date Received
- February 19, 2016
- Decision Date
- March 17, 2016
- Product Code
- PLO
- 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 |
|---|---|---|---|
| PLO | Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PLO), ordered by most recent decision date.
QIAstat-Dx Meningitis/Encephalitis (ME) Panel
FDA 510(k)
FDA Class 2
·Microbiology
Simplexa VZV Direct, Simplexa VZV Positive Control Pack
FDA 510(k)
FDA Class 2
·Microbiology
FilmArray Meningitis/Encephalitis(ME) Panel
FDA 510(k)
FDA Class 2
·Microbiology
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| K241194 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini | May 30, 2024 | Substantially Equivalent |
| K232954 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel | Mar 26, 2024 | Substantially Equivalent |
| K230719 | BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini | Apr 13, 2023 | Substantially Equivalent |
| K230404 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | Mar 16, 2023 | Substantially Equivalent |
| K222601 | FilmArray Pneumonia Panel plus | Oct 27, 2022 | Substantially Equivalent |
| DEN200066 | BioFire Joint Infection (JI) Panel | Apr 29, 2022 | Unknown |