FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FilmArray Pneumonia Panel plus
K Number: K181324
·
Decision Nov 15, 2018
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
28
Review Days
181
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Basic Information
- Device Name
- FilmArray Pneumonia Panel plus
- K Number
- K181324
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.4001
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biofire Diagnostics, LLC
- Date Received
- May 18, 2018
- Decision Date
- November 15, 2018
- Product Code
- QDS
- Advisory Committee
- Pathology
- 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 |
|---|---|---|---|
| QDS | Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System | FDA class 2 | Pathology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QDS), ordered by most recent decision date.
BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)
FDA 510(k)
FDA Class 2
·Pathology
FilmArray Pneumonia Panel plus
FDA 510(k)
FDA Class 2
·Pathology
Other Clearances by Biofire Diagnostics, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K243544 | BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini | Aug 14, 2025 | Substantially Equivalent |
| K243885 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid | Jan 16, 2025 | Substantially Equivalent |
| K243759 | BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)) | Dec 20, 2024 | Substantially Equivalent |
| K242367 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | Nov 7, 2024 | Substantially Equivalent |
| 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 |