FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
BioFire Respiratory Panel 2.1 (RP2.1)
K Number: DEN200031
·
Decision Mar 17, 2021
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
32
Applicant Total
28
Review Days
302
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Basic Information
- Device Name
- BioFire Respiratory Panel 2.1 (RP2.1)
- K Number
- DEN200031
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 866.3981
- Medical Specialty
- Microbiology
- Decision
- Unknown
- Applicant
- Biofire Diagnostics, LLC
- Date Received
- May 19, 2020
- Decision Date
- March 17, 2021
- Product Code
- QOF
- 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 |
|---|---|---|---|
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | FDA class 2 | Microbiology |
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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 |